Device and method for positioning an electrode in a body cavity

ABSTRACT

Electrical sensing/stimulation apparatuses for positioning at least one electrode within body tissue are provided. An electrical sensing/stimulation apparatus may comprise an elongate lead body having at least one internal lumen, at least one sensing/stimulation electrode, a deployable/retractable displacement member that moves or biases at least one electrode towards a prescribed direction by the user, a tissue attachment mechanism for affixing the distal segment of the device to body tissue, and an atraumatic distal lead body termination. In a retracted configuration, the attachment mechanism is positioned substantially within the distal segment of the lead body, and in the deployed configuration, the attachment mechanism extends from the axis of the lead body to engage body tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/990,998, filed May 9, 2014, which application is incorporated hereinby reference.

This application is related to U.S. patent application Ser. No.13/219,874, filed Aug. 29, 2011, entitled “Device and Method forPositioning an Electrode in Tissue” and U.S. Provisional PatentApplication Nos. 61/387,185, filed Sep. 28, 2010, entitled “RhythmSupport Device 2”; 61/412,992, filed Nov. 12, 2010, entitled “PacingDevice”; 61/420,060, filed Dec. 6, 2010, entitled, “Pacing Device”;61/427,306, filed Dec. 27, 2010, entitled “Rhythm Support Device 5”;61/445,992, filed Feb. 23, 2011, entitled, “Pacing Device”; and61/501,450, filed Jun. 27, 2011, entitled “Pacing Device”. The fulldisclosures of each of these applications are incorporated by referenceherein.

BACKGROUND Field of the Disclosure

The present disclosure relates generally to the sensing/stimulationelectrode devices and methods for their use, and more specifically tonovel devices and methods for more safe and reliable positioning of asensing/stimulation electrode within body tissue.

Bradycardia (reduced heart rate) is a common condition affectingmillions of patients annually. Although many such patients requireimplantation of permanent pacemaker devices to help regulate heart rate,other patients experience bradycardia with reversible causes that do notrequire permanent pacemaker implantation and may instead receivetemporary bradycardia support, such as over a period of less than oneweek. A common treatment for temporary bradycardia support involves asystem including transvenous electrode pacing leads that are inserteddirectly into the right ventricle of the heart to stimulate and regulatecardiac function. However, the conventional versions of these systemshave several drawbacks.

Thus, there are needs in the electrode stimulation device field for newand useful devices and methods for positioning an electrode in tissue.

SUMMARY

The present disclosure provides new and useful devices and methods forpositioning an electrode in tissue.

Embodiments of the present disclosure provide electricalsensing/stimulation apparatuses for positioning at least one electrodewithin body tissue. An electrical sensing/stimulation apparatus maycomprise an elongate lead body having at least one internal lumen; atleast one sensing/stimulation electrode; a deployable/retractabledisplacement member that moves or biases at least one electrode and/orat least one tissue attachment member towards a prescribed direction bythe user; a tissue attachment mechanism for affixing the distal segmentof the device to body tissue; and an atraumatic distal lead bodytermination. The tissue attachment mechanism may have a retractedconfiguration and a deployed configuration. In the retractedconfiguration, the mechanism may be positioned substantially within thedistal segment of the lead body, and in the deployed configuration, themechanism may extend from the axis of the lead body to engage bodytissue.

Embodiments of the present disclosure provide methods for positioning anelectrical sensing/stimulation device within body tissue. A method maycomprise the steps of navigating an elongate lead body to a targettissue (where the elongate lead body may comprise at least one internallumen, sensing/stimulation electrode(s), displacement member(s), tissueattachment member(s), tissue attachment deployment port(s), and anatraumatic distal tip); aligning the tissue attachment member(s) to thetarget tissue by using the lead's bi-directional torque control;deploying and/or expanding the displacement member(s) to bias the leadbody and tissue attachment member(s) deployment ports(s) andelectrode(s) against the target tissue; actuating the tissue attachmentmember(s) to extend from the tissue anchor deployment ports and into thetarget tissue, to affix the distal lead body and electrode(s) to thetarget body tissue; verifying the proper affixation of the device to thetarget; retracting and/or collapsing the displacement mechanism; and,retracting the tissue attachment member(s) after affixation to thetarget tissue, so as to release the affixation of the distal lead bodyand electrode(s) from the target body tissue.

Aspects of the present disclosure provide electrical sensing/stimulationapparatuses for positioning at least one electrode within body tissue.An electrical sensing/stimulation apparatus may comprise an elongatelead body, at least one sensing/stimulation electrode, adeployable/retractable displacement member, and a tissue attachmentmechanism. The elongate lead body may have a longitudinal axis. Thesensing/stimulation electrode(s) may be coupled to the elongate leadbody. The deployable/retractable displacement member may be coupled tothe elongate lead body and may be adapted to move or bias the at leastone electrode towards a prescribed direction by a user. The tissueattachment mechanism may be adapted to affix a distal segment of theelongate lead body to body tissue. The tissue attachment mechanism mayhave a retracted configuration and a deployed configuration. In theretracted configuration, the tissue attachment mechanism may bepositioned substantially within the at least one internal lumen. In thedeployed configuration, the tissue attachment mechanism may extend fromthe longitudinal axis of the elongate lead body to engage body tissue.The tissue attachment mechanism may comprise a plurality of tissueattachment members adapted to extend from a common port of the elongatelead body. Two or more of the tissue attachment members of the pluralityof tissue attachment members may be adapted to diverge from one anotherwhen extended from the common port.

The elongate lead body may have one or more ports through which thetissue attachment mechanism is configured to deploy. A proximal portionof the elongate lead body may be configured to couple with an externalgenerator. The proximal portion of the elongate lead body may beconfigured to couple with the external generator through a magneticcoupling. The proximal portion of the elongate lead body may beconfigured to couple with the external generator through an extensioncoupling adapted to axially lengthen or contract.

The sensing/stimulation electrode(s) may be mounted over or embeddedwithin an outer surface of a distal portion of the elongate lead bodysuch that a portion of the electrode(s) can be exposed at the outersurface of the elongate lead body. The at least one sensing/stimulationelectrode(s) comprises a first electrode and a second electrode. Thefirst electrode and second electrode may be axially separated from oneanother. The deployable/retractable displacement member may be disposedbetween the first and second electrodes.

The deployable/retractable displacement member may comprise anexpandable member having a collapsed configuration and an expandedconfiguration. The expandable member may be adapted to deploy out of alateral side of the elongate lead body. In some embodiments, theexpandable member in the collapsed configuration does not extend from anouter surface of the elongate lead body. The expandable member in thecollapsed configuration may have an outer perimeter greater than anouter circumference of the elongate lead body. The expandable member maybe at least partially folded onto itself in the collapsed configuration.The expandable member in the collapsed configuration may have aC-shaped, E-shaped, spiral shaped, serpentine shaped, or star shapedcross-section.

The electrical sensing/stimulation apparatus may further comprise aradiopaque marker mounted on an outer surface of the expandable member.The radiopaque marker may be expandable in conjunction with theexpandable marker. The expandable element may be inflatable. Theelongate lead body may have an inflation lumen to provide an inflationmedium to inflate the expandable element.

The expandable element may comprise a malecot or expandable cage.

The expandable element in the expanded configuration may be shaped tomatch the cavity of a bodily organ or space. The bodily organ or spacemay be at least a part of a right ventricle, a left ventricle, a rightatrium, a left atrium, an aorta, a vena cava, an artery, a vein, abladder, a ureter, a uterus, a nasal cavity, an oral cavity, anesophagus, a stomach, an intestine, a gall bladder, a colon, or arectum, but is not limited to such.

In the deployed configuration, the tissue attachment mechanism mayextend from the longitudinal axis of the elongate lead body to penetrateinto the body tissue.

The plurality of tissue attachment members may be adapted to extend fromthe longitudinal axis of the elongate lead body. One or more tissueattachment member of the plurality of tissue attachment members maycomprise a curved loop. Two or more tissue attachment members of theplurality of tissue attachment members may be configured to extend fromdifferent ports of the elongate lead body. Two or more of the tissueattachment members of the plurality of tissue attachment members may beadapted to be co-planar when extended.

The common port may have a length allowing the elongate lead body totranslate over a linear portion of one or more of the tissue attachmentmembers. One or more of the tissue attachment members may have a distalwire loop and a straightened distal-most portion distal of the distalwire loop.

Two or more of the tissue attachment members diverge from one another byan angle of less than or equal to 270 degrees, less than or equal to 180degrees, less than or equal to 90 degrees, to name a few examples.

The tissue attachment member(s) may comprise a hollow needle having aninner lumen through which one or more anchoring elements are advancedfrom when the at least one tissue attachment member is deployed.

The electrical sensing/stimulation apparatus may further comprise anatraumatic distal lead body termination. A distal end of the elongatelead body may comprise the atraumatic distal lead body termination. Theatraumatic distal lead body termination may comprise asensing/stimulation electrode. The atraumatic distal lead bodytermination may have a rounded, cobra-head, an elbowed, a bilateraleccentric, or a quad-eccentric tip, to name few examples. The atraumaticdistal lead body termination may comprises a plurality of radiallyextending outward tines.

The electrical sensing/stimulation apparatus may further comprise aproximal handle coupled to the elongate lead body. The proximal handlemay comprise one or more controls for one or more of activating the atleast one sensing/stimulation electrode, deploying or retracting thedeployable/retractable displacement member, or deploying or retractingthe tissue attachment mechanism. The proximal handle may comprise one ormore displays for indicating one or more of a relative position of thetissue attachment mechanism, a sensed resistance of tissue engaged bythe tissue attachment mechanism, or a sensed amount of current throughthe tissue engaged by the tissue attachment mechanism.

The elongate lead body may have an internal lumen and the electricalsensing/stimulation apparatus may further comprise a torque memberwithin the inner lumen and adapted to torque the elongate lead body. Thetorque member may be fixedly attached to the elongate lead body. Thetorque member may comprise a hypotube. The electricalsensing/stimulation apparatus may further comprise a shaping wireconfigured for placement within the internal lumen of the elongate leadbody to provide a predetermined shape to the elongate lead body. Theshaping wire may be configured to axially translate and/or rotate withinthe inner lumen. The shaping wire may be removable from the inner lumen.The shaping wire may be fixed within the inner lumen. The elongate leadbody may be rotatable about the shaping wire.

The elongate lead body may comprise an O-ring disposed in a proximalportion thereof. The O-ring may be adapted to prevent fluid from leakingproximally therethrough.

The plurality of tissue attachment members may have elongate proximalportions disposed within the elongate lead body when the tissueattachment mechanism is both retracted and deployed. The elongateproximal portions of the tissue attachment members may be housed withinan outer covering having a shape to provide an interference fit withinthe elongate lead body.

Aspects of the present disclosure also provide methods for positioningan electrical sensing/stimulation device within body tissue. An elongatelead body of the electrical sensing/stimulation device may be advancedto position the elongate lead body at a target site in a bodily cavity.The elongate lead body may be torqued to align at least one tissueattachment member of the electrical sensing/stimulation device with atarget tissue in the target site. A displacement member may be deployedto bias the elongate lead body and the at least one tissue attachmentmember against the target tissue. The tissue attachment member(s) may beactuated to extend from at least one tissue anchor deployment port onthe elongate lead body and into the target tissue to affix a distalportion of the elongate lead body and the electrode(s) of the electricalsensing/stimulation device to the target tissue. The tissue attachmentmember(s) may comprise a plurality of tissue attachment members. Theplurality of tissue attachment members may be actuated to extend from acommon tissue deployment port. Two or more attachment members maydiverge from one another when deployed from the common tissue deploymentport.

Proper affixation of the distal portion of the elongate lead body to thetarget tissue may be verified, such as by fluoroscopically imaging thebodily cavity with the elongate lead body positioned therein. Influoroscopically imaging the bodily cavity, one or more radiopaquemarkers coupled to one or more of the elongate lead body, the tissueattachment member(s), or the displacement member may be identified.

A physiological parameter, such as cardiac electrical activity or bloodpressure, may be sensed with the electrode(s) affixed to the targettissue and/or the target tissue may be electrically stimulated with theelectrode(s).

The displacement member may be collapsed and the tissue attachmentmember may be retracted after affixation to the target tissue, so as torelease the affixation of the distal portion of the elongate lead bodyand the electrode(s) from the target tissue.

To advance the elongate lead body, an internal shaping wire may bepositioned through an internal lumen of the elongate lead body to imparta predetermined shape to the elongate lead body. The predetermined shapemay facilitate advancement of the elongate lead body through a bodilylumen.

To torque the elongate lead body, a torque member may be disposed withinan internal lumen of the elongate lead body. The displacement member maybe deployed from a lateral side of the elongate lead body. Thedisplacement member may be expanded, such as to a shape matching a shapeof the bodily cavity. The displacement member may comprise an expandableelement and the displacement member may be deployed by inflating theexpandable member.

Two or more tissue attachment members of the plurality of tissueattachment members may be deployed from different tissue deploymentports. The two or more attachment members may be coplanar with oneanother when deployed from the different tissue deployment ports. Thetwo or more tissue attachment members may deploy with an angle betweenthe deployment planes of the tissue attachment members.

The tissue attachment member(s) may extend from a longitudinal axis ofthe elongate lead body when deployed. A proximal portion of the elongatelead body may be coupled with an external generator. The proximalportion of the elongate lead body may be coupled with the externalgenerator through a magnetic coupling. The proximal portion of theelongate lead body may be coupled with the external generator through anextension coupling adapted to axially lengthen or contract. A movementof the affixed tissue attachment member(s) relative to the elongate leadbody may be sensed. The sensed movement may be displayed on a handlecoupled to the elongate lead body.

The target bodily cavity may be at least a part of a right ventricle, aleft ventricle, a right atrium, a left atrium, an aorta, a vena cava, anartery, a vein, a bladder, a ureter, a uterus, a nasal cavity, an oralcavity, an esophagus, a stomach, an intestine, a gall bladder, a colon,or a rectum.

Aspects of the present disclosure may also provide further electricalsensing/stimulation apparatuses for positioning at least one electrodewithin body tissue. An electrical sensing/stimulation apparatus maycomprise an elongate lead body, at least one sensing/stimulationelectrode, an expandable displacement member, and a tissue attachmentmechanism. The elongate lead body having a longitudinal axis. Thesensing/stimulation electrode may be coupled to the elongate lead body.The expandable displacement member may be coupled to the elongate leadbody and adapted to move or bias the at least one electrode towards aprescribed direction by a user. The expandable displacement member mayhave a shape matching a cavity of a bodily organ or space when expanded.The tissue attachment mechanism may be adapted to affix a distal segmentof the elongate lead body to body tissue. The tissue attachmentmechanism may have a retracted configuration and a deployedconfiguration. In the retracted configuration, the tissue attachmentmechanism may be positioned substantially within the at least oneinternal lumen. In the deployed configuration, the tissue attachmentmechanism may extend from the longitudinal axis of the elongate leadbody to engage body tissue.

The sensing/stimulation electrode(s) may comprise a first electrode anda second electrode, which may be axially separated from one another,such that the expandable displacement member is disposed between thefirst and second electrodes, for example.

In many embodiments, the expandable member when collapsed does notextend from an outer surface of the elongate lead body. The expandablemember when collapsed may have an outer perimeter greater than an outercircumference of the elongate lead body. The expandable displacementmember may at least partially fold onto itself in the collapsedconfiguration. The expandable member in the collapsed configuration mayhave a C-shaped, E-shaped, spiral shaped, serpentine shaped, or starshaped cross-section. A radiopaque marker may be mounted on an outersurface of the expandable displacement member. The radiopaque marker maybe expandable in conjunction with the expandable marker. The expandabledisplacement member may be inflatable. The elongate lead body may havean inflation lumen to provide an inflation medium to inflate theexpandable displacement member. Alternatively or in combination, theexpandable displacement member may comprise a malecot or expandablecage. The bodily organ or space that matches the shape of the expandedexpandable displacement member may be at least a part of a rightventricle, a left ventricle, a right atrium, a left atrium, an aorta, avena cava, an artery, a vein, a bladder, a ureter, a uterus, a nasalcavity, an oral cavity, an esophagus, a stomach, an intestine, a gallbladder, a colon, or a rectum, to name a few.

The elongate lead body may have one or more ports through which thetissue attachment mechanism is configured to deploy.

A proximal portion of the elongate lead body may be configured to couplewith an external generator. The proximal portion of the elongate leadbody may be configured to couple with the external generator through amagnetic coupling. The proximal portion of the elongate lead body may beconfigured to couple with the external generator through an extensioncoupling adapted to axially lengthen or contract.

In the deployed configuration, the tissue attachment mechanism mayextend from the longitudinal axis of the elongate lead body to penetrateinto the body tissue. The plurality of tissue attachment members may beadapted to extend from the longitudinal axis of the elongate lead body.One or more tissue attachment member of the plurality of tissueattachment members comprises a curved loop. Two or more tissueattachment members of the plurality of tissue attachment members may beconfigured to extend from different ports of the elongate lead body. Thetwo or more of the tissue attachment members of the plurality of tissueattachment members may be adapted to be co-planar when extended.

A port through which the tissue attachment mechanism deploys may have alength allowing the elongate lead body to translate over a linearportion of one or more of the tissue attachment members. One or more ofthe tissue attachment members may have a distal wire loop and astraightened distal-most portion distal of the distal wire loop.

Two or more of the tissue attachment members may diverge from oneanother by an angle of less than or equal to 270 degrees, less than orequal to 180 degrees, less than or equal to 90 degrees, to name a fewexamples. The tissue attachment member may comprise a hollow needlehaving an inner lumen through which one or more anchoring elements areadvanced from when the at least one tissue attachment member isdeployed.

The electrical sensing/stimulation apparatus may further comprise anatraumatic distal lead body termination. A distal end of the elongatelead body may comprise the atraumatic distal lead body termination. Theatraumatic distal lead body termination may comprise asensing/stimulation electrode. The atraumatic distal lead bodytermination may have a rounded, cobra-head, an elbowed, a bilateraleccentric, or a quad-eccentric tip, to name a few examples. Theatraumatic distal lead body termination may comprise a plurality ofradially extending outward tines.

The electrical sensing/stimulation apparatus may further comprise aproximal handle coupled to the elongate lead body. The proximal handlemay comprise one or more controls for one or more of activating the atleast one sensing/stimulation electrode, deploying or retracting thedeployable/retractable displacement member, or deploying or retractingthe tissue attachment mechanism. The proximal handle may comprise one ormore displays for indicating one or more of a relative position of thetissue attachment mechanism, a sensed resistance of tissue engaged bythe tissue attachment mechanism, or a sensed amount of current throughthe tissue engaged by the tissue attachment mechanism.

The elongate lead body may have an internal lumen, and the electricalsensing/stimulation apparatus may further comprise a torque memberwithin the inner lumen and adapted to torque the elongate lead body. Thetorque member may be fixedly attached to the elongate lead body. Thetorque member may comprise a hypotube or tubular braided wireconstruction laminated with polymer. The electrical sensing/stimulationapparatus may further comprise a shaping wire configured for placementwithin the internal lumen of the elongate lead body to provide apredetermined shape to the elongate lead body. The shaping wire may beconfigured to axially translate and/or rotate within the inner lumen.The shaping wire may be removable from the inner lumen. The shaping wiremay be fixed within the inner lumen. The elongate lead body may berotatable about the shaping wire.

The elongate lead body may comprise an O-ring disposed in a proximalportion thereof. The O-ring may be adapted to prevent fluid from leakingproximally therethrough.

The plurality of tissue attachment members may have elongate proximalportions disposed within the elongate lead body when the tissueattachment mechanism is both retracted and deployed. The elongateproximal portions of the tissue attachment members may be housed withinan outer covering having a shape to provide an interference fit withinthe elongate lead body.

Aspects of the present disclosure may provide a method for positioningan electrical sensing/stimulation device within body tissue. An elongatelead body of the electrical sensing/stimulation device may be advancedto position the elongate lead body at a target site in a bodily cavity.The elongate lead body may be torqued to align at least one tissueattachment member of the electrical sensing/stimulation device with atarget tissue in the target site. A displacement member may be expandedto bias the elongate lead body and the at least one tissue attachmentmember against the target tissue, the expanded displacement memberhaving a shape that may match the bodily cavity. At least one tissueattachment member may be actuated to extend from at least one tissueanchor deployment port on the elongate lead body and into the targettissue to affix a distal portion of the elongate lead body and at leastone electrode of the electrical sensing/stimulation device to the targettissue.

After affixation to the target tissue, the displacement member may becollapsed and the at least one tissue attachment member may be retractedso as to release the affixation of the distal portion of the elongatelead body and the at least one electrode from the target tissue.

The displacement member may be expanded outwardly from a lateral side ofthe elongate lead body.

The displacement member may comprise an expandable element and thedisplacement member may be deployed by inflating the expandable member.

The bodily organ or space that matches the shape of the expandedexpandable displacement member may be at least a part of a rightventricle, a left ventricle, a right atrium, a left atrium, an aorta, avena cava, an artery, a vein, a bladder, a ureter, a uterus, a nasalcavity, an oral cavity, an esophagus, a stomach, an intestine, a gallbladder, a colon, or a rectum, to name a few.

Proper affixation of the distal portion of the elongate lead body to thetarget tissue may be verified, such as by fluoroscopically imaging thebodily cavity with the elongate lead body positioned therein. Influoroscopically imaging the bodily cavity, one or more radiopaquemarkers coupled to one or more of the elongate lead body, the at leastone tissue attachment member, or the displacement member may beidentified.

A physiological parameter, such as cardiac electrical activity or bloodpressure, may be sensed with the electrode(s) affixed to the targettissue and/or the target tissue may be electrically stimulated with theelectrode(s).

To advance the elongate lead body, an internal shaping wire may bepositioned through an internal lumen of the elongate lead body to imparta predetermined shape to the elongate lead body. The predetermined shapemay facilitate advancement of the elongate lead body through a bodilylumen.

To torque the elongate lead body, a torque member may be disposed withinan internal lumen of the elongate lead body. The displacement member maybe deployed from a lateral side of the elongate lead body. Thedisplacement member may be expanded, such as to a shape matching a shapeof the bodily cavity. The displacement member may comprise an expandableelement and the displacement member may be deployed by inflating theexpandable member.

Two or more tissue attachment members of the plurality of tissueattachment members may be deployed from different tissue deploymentports. The two or more attachment members may be coplanar with oneanother when deployed from the different tissue deployment ports, or thedeployment planes of the loops of the tissue attachment members may beconfigured with an angle separating them. The two or more tissueattachment members may deploy with an angle between the deploymentplanes of the tissue attachment members.

The tissue attachment member(s) may extend from a longitudinal axis ofthe elongate lead body when deployed. A proximal portion of the elongatelead body may be coupled with an external generator. The proximalportion of the elongate lead body may be coupled with the externalgenerator through a magnetic coupling. The proximal portion of theelongate lead body may be coupled with the external generator through anextension coupling adapted to axially lengthen or contract. A movementof the affixed tissue attachment member(s) relative to the elongate leadbody may be sensed. The sensed movement may be displayed on a handlecoupled to the elongate lead body. The bodily cavity may be at least apart of a right ventricle, a left ventricle, a right atrium, a leftatrium, an aorta, a vena cava, an artery, a vein, a bladder, a ureter, auterus, a nasal cavity, an oral cavity, an esophagus, a stomach, anintestine, a gall bladder, a colon, or a rectum.

Aspects of the present disclosure may also provide an electricalsensing/stimulation apparatus for positioning at least one electrodewithin body tissue. The electrical sensing/stimulation apparatus maycomprise an elongate lead body, at least one sensing/stimulationelectrode, a deployable/retractable displacement member, a tissueattachment mechanism, and a shaping wire. The elongate lead body mayhave a longitudinal axis. The sensing/stimulation electrode(s) may becoupled to the elongate lead body. The deployable/retractabledisplacement member may be coupled to the elongate lead body and may beadapted to move or bias the electrode(s) towards a prescribed directionby a user. The tissue attachment mechanism may be adapted to affix adistal segment of the elongate lead body to body tissue. The tissueattachment mechanism may have a retracted configuration and a deployedconfiguration. In the retracted configuration, the tissue attachmentmechanism may be positioned substantially within the at least oneinternal lumen. In the deployed configuration, the tissue attachmentmechanism may extend from the longitudinal axis of the elongate leadbody to engage body tissue. The shaping wire may be configured forplacement within an internal lumen of the elongate lead body to providea predetermined shape to the elongate lead body.

The shaping wire may be configured to axially translate and/or rotatewithin the inner lumen. The shaping wire may be removable from the innerlumen. The shaping wire may be fixed within the inner lumen. Theelongate lead body may be rotatable about the shaping wire.

The electrical sensing/stimulation apparatus may further comprise atorque member within the inner lumen adapted to torque the elongate leadbody. The shaping wire may be configured to be disposed within thetorque member. The shaping wire may be selectively curved by the user.

The elongate lead body may have one or more ports through which thetissue attachment mechanism is configured to deploy. A proximal portionof the elongate lead body may be configured to couple with an externalgenerator. The proximal portion of the elongate lead body may beconfigured to couple with the external generator through a magneticcoupling. The proximal portion of the elongate lead body may beconfigured to couple with the external generator through an extensioncoupling adapted to axially lengthen or contract.

The sensing/stimulation electrode(s) may be mounted over or embeddedwithin an outer surface of a distal portion of the elongate lead bodysuch that a portion of the electrode(s) can be exposed at the outersurface of the elongate lead body. The at least one sensing/stimulationelectrode(s) comprises a first electrode and a second electrode. Thefirst electrode and second electrode may be axially separated from oneanother. The deployable/retractable displacement member may be disposedbetween the first and second electrodes.

The deployable/retractable displacement member may comprise anexpandable member having a collapsed configuration and an expandedconfiguration. The expandable member may be adapted to deploy out of alateral side of the elongate lead body. In some embodiments, theexpandable member in the collapsed configuration does not extend from anouter surface of the elongate lead body. The expandable member in thecollapsed configuration may have an outer perimeter greater than anouter circumference of the elongate lead body. The expandable member maybe at least partially folded onto itself in the collapsed configuration.The expandable member in the collapsed configuration may have aC-shaped, E-shaped, spiral shaped, serpentine shaped, or star shapedcross-section.

The electrical sensing/stimulation apparatus may further comprise aradiopaque marker mounted on or embedded within an outer surface of theexpandable member. The radiopaque marker may be expandable inconjunction with the expandable marker. The expandable element may beinflatable. The elongate lead body may have an inflation lumen toprovide an inflation medium to inflate the expandable element.

The expandable element may comprise a malecot or expandable cage

In the deployed configuration, the tissue attachment mechanism mayextend from the longitudinal axis of the elongate lead body to penetrateinto the body tissue.

The plurality of tissue attachment members may be adapted to extend fromthe longitudinal axis of the elongate lead body. One or more tissueattachment member of the plurality of tissue attachment members maycomprise a curved loop. Two or more tissue attachment members of theplurality of tissue attachment members may be configured to extend fromdifferent ports of the elongate lead body. Two or more of the tissueattachment members of the plurality of tissue attachment members may beadapted to be co-planar when extended. Two or more tissue attachmentmembers of the plurality of tissue attachment members may be configuredto extend from a common port of the elongate body. Two or more of thetissue attachment members of the plurality of tissue attachment membersmay be adapted such that the plane of deployment of the tissueattachment members may be at an angle to each other when extended.

A port through which the tissue attachment mechanism deploys may have alength allowing the elongate lead body to translate over a linearportion of one or more of the tissue attachment members. One or more ofthe tissue attachment members have a distal wire loop and a straighteneddistal-most portion distal of the distal wire loop.

Two or more of the tissue attachment members diverge from one another byan angle of less than or equal to 270 degrees, less than or equal to 180degrees, less than or equal to 90 degrees, to name a few examples.

The tissue attachment member(s) may comprise a hollow needle having aninner lumen through which one or more anchoring elements are advancedfrom when the at least one tissue attachment member is deployed.

The electrical sensing/stimulation apparatus may further comprise anatraumatic distal lead body termination. A distal end of the elongatelead body may comprise the atraumatic distal lead body termination. Theatraumatic distal lead body termination may comprise asensing/stimulation electrode. The atraumatic distal lead bodytermination may have a rounded, cobra-head, an elbowed, a bilateraleccentric, or a quad-eccentric tip, to name few examples. The atraumaticdistal lead body termination may comprises a plurality of radiallyextending outward tines.

The electrical sensing/stimulation apparatus may further comprise aproximal handle coupled to the elongate lead body. The proximal handlemay comprise one or more controls for one or more of activating the atleast one sensing/stimulation electrode, deploying or retracting thedeployable/retractable displacement member, or deploying or retractingthe tissue attachment mechanism. The proximal handle may comprise one ormore displays for indicating one or more of a relative position of thetissue attachment mechanism, a sensed resistance of tissue engaged bythe tissue attachment mechanism, or a sensed amount of current throughthe tissue engaged by the tissue attachment mechanism.

The elongate lead body may have an internal lumen and the electricalsensing/stimulation apparatus may further comprise a torque memberwithin an inner lumen of the elongate lead body and adapted to torquethe elongate lead body. The torque member may be fixedly attached to theelongate lead body. The torque member may comprise a hypotube or a wirebraided tubular structure laminated with polymer. The electricalsensing/stimulation apparatus may further comprise a shaping wireconfigured for placement within the internal lumen of the elongate leadbody to provide a predetermined shape to the elongate lead body. Theshaping wire may be configured to axially translate and/or rotate withinthe inner lumen. The shaping wire may be removable from the inner lumen.The shaping wire may be fixed within the inner lumen. The elongate leadbody or torque member may be rotatable about the shaping wire.

The elongate lead body may comprise an O-ring disposed in a proximalportion thereof. The O-ring may be adapted to prevent fluid from leakingproximally therethrough.

The plurality of tissue attachment members may have elongate proximalportions disposed within the elongate lead body when the tissueattachment mechanism is both retracted and deployed. The elongateproximal portions of the tissue attachment members may be housed withinan outer covering having a shape to provide an interference fit withinthe elongate lead body.

Aspects of the present disclosure may also provide methods forpositioning an electrical sensing/stimulation device within body tissue.An elongate lead body of the electrical sensing/stimulation device maybe advanced to position the elongate lead body at a target site in abodily cavity. An internal shaping wire may be affixed within oradvanced axially and positioned through an internal lumen of theelongate lead body to impart a predetermined shape to the elongate leadbody, thereby facilitating advancement of the elongate lead body througha bodily lumen. The elongate lead body may be torqued to align at leastone tissue attachment member of the electrical sensing/stimulationdevice with a target tissue in the target site. A displacement membermay be deployed to bias the elongate lead body and the tissue attachmentmember(s) against the target tissue. The tissue attachment member(s) maybe actuated to extend from at least one tissue anchor deployment port onthe elongate lead body and into the target tissue to affix a distalportion of the elongate lead body and electrode(s) of the electricalsensing/stimulation device to the target tissue.

Proper affixation of the distal portion of the elongate lead body to thetarget tissue may be verified, such as by fluoroscopically imaging thebodily cavity with the elongate lead body positioned therein. Influoroscopically imaging the bodily cavity, one or more radiopaquemarkers coupled to one or more of the elongate lead body, the tissueattachment member(s), or the displacement member may be identified.

A physiological parameter, such as cardiac electrical activity or bloodpressure, may be sensed with the electrode(s) affixed to the targettissue and/or the target tissue may be electrically stimulated with theelectrode(s).

The displacement member may be collapsed and the tissue attachmentmember(s) may be retracted after affixation to the target tissue, so asto release the affixation of the distal portion of the elongate leadbody and the electrode(s) from the target tissue.

An internal shaping wire may be positioned through an internal lumen ofthe elongate lead body to impart a predetermined shape to the elongatelead body, for example, to facilitate advancement of the elongate leadbody through a bodily lumen.

To torque the elongate lead body, a torque member may be disposed withinan internal lumen of the elongate lead body. The displacement member maybe deployed from a lateral side of the elongate lead body. Thedisplacement member may be expanded, such as to a shape matching a shapeof the bodily cavity. The displacement member may comprise an expandableelement and the displacement member may be deployed by inflating theexpandable member.

Two or more tissue attachment members of the plurality of tissueattachment members may be deployed from different tissue deploymentports, or from a common deployment port. The two or more attachmentmembers may be coplanar with one another when deployed from thedifferent tissue deployment ports. The two or more tissue attachmentmembers may deploy with an angle between the deployment planes of thetissue attachment members or the tissue attachment members may bedeployed at an angle to each other.

The tissue attachment member(s) may extend from a longitudinal axis ofthe elongate lead body when deployed. A proximal portion of the elongatelead body may be coupled with an external generator. The proximalportion of the elongate lead body may be coupled with the externalgenerator through a magnetic coupling. The proximal portion of theelongate lead body may be coupled with the external generator through anextension coupling adapted to axially lengthen or contract. A movementof the affixed tissue attachment member(s) relative to the elongate leadbody may be sensed. The sensed movement may be displayed on a handlecoupled to the elongate lead body.

The target bodily cavity may be at least a part of a right ventricle, aleft ventricle, a right atrium, a left atrium, an aorta, a vena cava, anartery, a vein, a bladder, a ureter, a uterus, a nasal cavity, an oralcavity, an esophagus, a stomach, an intestine, a gall bladder, a colon,or a rectum. Aspects of the present disclosure may also provideelectrical sensing/stimulation apparatuses for positioning at least oneelectrode within body tissue. The electrical sensing/stimulationapparatus may comprise an elongate lead body, at least onesensing/stimulation electrode, a deployable/retractable displacementmember, a tissue attachment mechanism, and a torque member. The elongatelead body may have a longitudinal axis and an inner lumen. Thesensing/stimulation electrode may be coupled to the elongate lead body.The deployable/retractable displacement member may be coupled to theelongate lead body and adapted to move or bias the at least oneelectrode and/or the at least one attachment member towards a prescribeddirection by a user. The tissue attachment mechanism may be adapted toaffix a distal segment of the elongate lead body to body tissue. Thetissue attachment mechanism may have a retracted configuration and adeployed configuration. In the retracted configuration, the tissueattachment mechanism may be positioned substantially within the at leastone internal lumen. In the deployed configuration, the tissue attachmentmechanism may extend from the longitudinal axis of the elongate leadbody to engage body tissue. The torque member may be positioned withinthe inner lumen of the elongate lead body adapted to torque the elongatelead body.

The torque member may be fixedly attached to the elongate lead body. Thetorque member may comprise a hypotube or a braided wire tubularstructure laminated with polymer. The elongate lead body may have one ormore ports through which the tissue attachment mechanism is configuredto deploy. A proximal portion of the elongate lead body may beconfigured to couple with an external generator. The proximal portion ofthe elongate lead body may be configured to couple with the externalgenerator through a magnetic coupling. The proximal portion of theelongate lead body may be configured to couple with the externalgenerator through an extension coupling adapted to axially lengthen orcontract.

The sensing/stimulation electrode(s) may be mounted over or embeddedwithin an outer surface or embedded within the surface of a distalportion of the elongate lead body such that a portion of the electrodecan be exposed at the outer surface of the elongate lead body. The atleast one sensing/stimulation electrode(s) comprises a first electrodeand a second electrode. The first electrode and second electrode may beaxially separated from one another. The deployable/retractabledisplacement member may be disposed between the first and secondelectrodes.

The deployable/retractable displacement member may comprise anexpandable member having a collapsed configuration and an expandedconfiguration. The expandable member may be adapted to deploy out of alateral side of the elongate lead body. In some embodiments, theexpandable member in the collapsed configuration does not extend from anouter surface of the elongate lead body. The expandable member in thecollapsed configuration may have an outer perimeter greater than anouter circumference of the elongate lead body. The expandable member maybe at least partially folded onto itself in the collapsed configuration.The expandable member in the collapsed configuration may have aC-shaped, E-shaped, spiral shaped, serpentine shaped, or star shapedcross-section.

The electrical sensing/stimulation apparatus may further comprise aradiopaque marker mounted on an outer surface of the expandable member.The radiopaque marker may be expandable in conjunction with theexpandable marker. The expandable element may be inflatable. Theelongate lead body may have an inflation lumen to provide an inflationmedium to inflate the expandable element.

The expandable element may comprise a malecot or expandable cage.

In the deployed configuration, the tissue attachment mechanism mayextend from the longitudinal axis of the elongate lead body to penetrateinto the body tissue.

The plurality of tissue attachment members may be adapted to extend fromthe longitudinal axis of the elongate lead body. One or more tissueattachment member of the plurality of tissue attachment members maycomprise a curved loop. Two or more tissue attachment members of theplurality of tissue attachment members may be to extend from differentports of the elongate lead body. Two or more of the tissue attachmentmembers of the plurality of tissue attachment members may be adapted tobe co-planar when extended or their deployment planes may be angled toeach other.

The common port may have a length allowing the elongate lead body totranslate over a linear portion of one or more of the tissue attachmentmembers. One or more of the tissue attachment members may have a distalwire loop and a straightened distal-most portion distal of the distalwire loop.

Two or more of the tissue attachment members diverge from one another byan angle of less than or equal to 270 degrees, less than or equal to 180degrees, less than or equal to 90 degrees, to name a few examples.

The tissue attachment member(s) may comprise a hollow needle having aninner lumen through which one or more anchoring elements are advancedfrom when the at least one tissue attachment member is deployed.

The electrical sensing/stimulation apparatus may further comprise anatraumatic distal lead body termination. A distal end of the elongatelead body may comprise the atraumatic distal lead body termination. Theatraumatic distal lead body termination may comprise asensing/stimulation electrode. The atraumatic distal lead bodytermination may have a rounded, cobra-head, an elbowed, a bilateraleccentric, or a quad-eccentric tip, to name few examples. The atraumaticdistal lead body termination may comprises a plurality of radiallyextending outward tines.

The electrical sensing/stimulation apparatus may further comprise aproximal handle coupled to the elongate lead body. The proximal handlemay comprise one or more controls for one or more of activating the atleast one sensing/stimulation electrode, deploying or retracting thedeployable/retractable displacement member, or deploying or retractingthe tissue attachment mechanism. The proximal handle may comprise one ormore displays for indicating one or more of a relative position of thetissue attachment mechanism, a sensed resistance of tissue engaged bythe tissue attachment mechanism, or a sensed amount of current throughthe tissue engaged by the tissue attachment mechanism.

The elongate lead body may comprise an O-ring disposed in a proximalportion thereof. The O-ring may be adapted to prevent fluid from leakingproximally therethrough.

The plurality of tissue attachment members may have elongate proximalportions disposed within the elongate lead body when the tissueattachment mechanism is both retracted and deployed. The elongateproximal portions of the tissue attachment members may be housed withinan outer covering having a shape to provide an interference fit withinthe elongate lead body.

Aspects of the present disclosure may provide methods for positioning anelectrical sensing/stimulation device within body tissue. An elongatelead body of the electrical sensing/stimulation device may be advancedto position the elongate lead body at a target site in a bodily cavity.A torque member disposed within an inner lumen of the elongate lead bodymay be torqued to torque or axially rotate the elongate lead body toalign at least one tissue attachment member of the electricalsensing/stimulation device with a target tissue in the target site. Adisplacement member may be deployed to bias the elongate lead body andthe tissue attachment member(s) against the target tissue. The tissueattachment member may be actuated to extend from at least one tissueanchor deployment port on the elongate lead body and into the targettissue to affix a distal portion of the elongate lead body and theelectrode(s) of the electrical sensing/stimulation device to the targettissue.

Proper affixation of the distal portion of the elongate lead body to thetarget tissue may be verified, such as by fluoroscopically imaging thebodily cavity with the elongate lead body positioned therein. Influoroscopically imaging the bodily cavity, one or more radiopaquemarkers coupled to one or more of the elongate lead body, the tissueattachment member(s), or the displacement member may be identified.

A physiological parameter, such as cardiac electrical activity or bloodpressure, may be sensed with the electrode(s) affixed to the targettissue and/or the target tissue may be electrically stimulated with theelectrode(s).

The displacement member may be collapsed and the tissue attachmentmember may be retracted after affixation to the target tissue, so as torelease the affixation of the distal portion of the elongate lead bodyand the electrode(s) from the target tissue.

The displacement member may be deployed from a lateral side of theelongate lead body, such as by expanding the displacement member. Thedisplacement member may be expanded to a shape matching a shape of thebodily cavity. The displacement member may comprise an expandableelement and the displacement member may be deployed by inflating theexpandable member. Two or more tissue attachment members of theplurality of tissue attachment members may be deployed from differenttissue deployment ports or from a common deployment port. The two ormore attachment members may be coplanar with one another when deployedfrom the different tissue deployment ports or the common delivery port,or the planes of the tissue attachment members may be deployed at anangle to each other. The two or more tissue attachment members maydeploy with an angle between the deployment planes of the tissueattachment members.

At least one tissue attachment member may extend from a longitudinalaxis of the elongate lead body when deployed. A proximal portion of theelongate lead body may be coupled with an external generator. Theproximal portion of the elongate lead body may be coupled with theexternal generator through a magnetic coupling. The proximal portion ofthe elongate lead body may be coupled with the external generatorthrough an extension coupling adapted to axially lengthen or contract. Amovement of the affixed tissue attachment member(s) relative to theelongate lead body may be sensed. The sensed movement may be displayedon a handle coupled to the elongate lead body.

The target bodily cavity may be at least a part of a right ventricle, aleft ventricle, a right atrium, a left atrium, an aorta, a vena cava, anartery, a vein, a bladder, a ureter, a uterus, a nasal cavity, an oralcavity, an esophagus, a stomach, an intestine, a gall bladder, a colon,or a rectum.

BRIEF DESCRIPTION OF THE DRAWINGS

It should be noted that the drawings are not to scale and are intendedonly as an aid in conjunction with the explanations in the followingdetailed description. In the drawings, identical reference numbersidentify similar elements or acts. The sizes and relative positions ofelements in the drawings are not necessarily drawn to scale. Forexample, the shapes of various elements and angles may not be drawn toscale, and some of these elements may be arbitrarily enlarged andpositioned to improve drawing legibility. Further, the particular shapesof the elements as drawn, are not intended to convey any informationregarding the actual shape of the particular elements, and have beensolely selected for ease of recognition in the drawings. A betterunderstanding of the features and advantages of the present disclosurewill be obtained by reference to the following detailed description thatsets forth illustrative embodiments, in which the principles of thedisclosure are utilized, and the accompanying drawings.

FIG. 1a shows a side view of the Distal Lead Segment of an electricalsensing/stimulation device, with the Tissue Attachment Members retractedand Balloon deflated, according to many embodiments.

FIG. 1b shows a side view of the Distal Lead Segment of the electricalsensing/stimulation device of FIG. 1a , with the Tissue AttachmentMembers deployed and Balloon inflated.

FIG. 2a shows a side view of the Distal Lead Body of the electricalsensing/stimulation device of FIG. 1a —showing longitudinal cut-outthrough which the Balloon expands when inflated.

FIG. 2b shows a top view of the Distal Lead Body of FIG. 2a —showingsmall cut-outs for passage of the Ring Electrode Wires and the TissueAttachment Members.

FIG. 2c shows a perspective view of the end of the Distal Lead Body ofthe FIG. 2a —showing the main central lumen within which is mounted theBalloon; the two small circular lumens, each of which houses a RingElectrode Conductor Wire; and the small oval lumen, within whichtranslates the Tissue Attachment Members.

FIGS. 3a-3c show the Balloon of the electrical sensing/stimulationdevice of FIG. 1a mounted on a D-shaped longitudinal Element to producean Inflatable Element Cartridge, according to many embodiments. Thissub-assembly may be inserted into the main D-shaped lumen of the DistalLead Body.

FIG. 3a shows a side, perspective view of the Inflatable ElementCartridge.

FIG. 3a ′ shows a section view of the Inflatable Element Cartridge withthe Balloon in a collapsed configuration.

FIG. 3a ″ shows a section view of the Inflatable Element Cartridge withthe Balloon in an expanded configuration.

FIG. 3b show a side view of the Inflatable Element Cartridge separatedfrom the Distal Lead Body.

FIG. 3c shows a side view of the Inflatable Element Cartridge coupled tothe Distal Lead Body.

FIGS. 4a-4d show another Inflatable Displacement Member mounted withinthe Distal Lead Body of an electrical sensing/stimulation device,according to many embodiments.

FIG. 4a shows a side view of the Distal Lead Body.

FIG. 4b shows a side view of an Inflatable Displacement Member.

FIG. 4c shows a side view of the Inflatable Displacement Memberseparated from the Distal Lead Body.

FIG. 4d shows a side view of the Inflatable Displacement Member coupledto the Distal Lead Body.

FIGS. 5a-5e depict another Inflatable Displacement Member, which may bemounted on a Cartridge in a helical fashion and mounted within theDistal Lead Body of an electrical sensing/stimulation device, accordingto many embodiments.

FIG. 5a shows a side view of the Cartridge.

FIG. 5b shows a side view the Inflatable Displacement Member.

FIG. 5c shows a side view of the Cartridge mounted InflatableDisplacement Member.

FIG. 5d shows a side view of the Cartridge mounted InflatableDisplacement Member separated from the Distal Lead Body.

FIG. 5e shows a side view of the Cartridge Mounted InflatableDisplacement Member coupled to the Distal Lead Body.

FIG. 6a shows a perspective view of the insertion/keying of the TissueAttachment Members into the oval channel of the Distal Lead Body of anelectrical sensing/stimulation device, according to many embodiments.

FIG. 6a ′ shows a perspective view of other Tissue Attachment Members,wherein these Tissue Attachment Members may be deployed by retracting anactuation wire.

FIG. 6b shows a magnified perspective view of the insertion/keying ofthe Tissue Attachment Members into the oval channel of the Distal LeadBody.

FIG. 6c shows a section view of the positioning of the Tissue AttachmentMembers into the oval channel of the Distal Lead Body, the mountingposition of the Electrodes and associated Electrode Wires, and theposition of the internal Torque Control Member.

FIG. 7a shows a perspective view of a selective cut-out of the top ofthe Distal Lead Body of an electrical sensing/stimulation device,showing the Tissue Attachment Members in their retracted, straightconfiguration within the oval lumen, and the Ring Electrode Wires intheir respective lumens, according to many embodiments.

FIG. 7b shows a perspective view of a partial assembly of the DistalLead Segment of FIG. 7a showing the Tissue Anchors in their deployedconfiguration.

FIG. 7b ′ shows a side view of the Distal Lead Segment of FIG. 7ashowing the Distal Lead Segment with the Tissue Anchors in theirretracted configuration, and various shapes of the electrode to provideradiographic orientation of the Distal Lead Segment.

FIGS. 8a-8d depict various Distal Tips of the Distal Lead Segment,according to many embodiments.

FIG. 8a shows a perspective view of a Distal Tip.

FIG. 8b shows a perspective view of another Distal Tip.

FIG. 8c shows a perspective view of another Distal Tip.

FIG. 8d shows a perspective view of another Distal Tip.

FIGS. 9a, 9b, and 9c show side views of Torque Control Members,according to many embodiments.

FIG. 10 shows a side view of a Lead Handle and actuation/lockingmechanism, according to many embodiments.

FIG. 10a shows a side view of a Lead Handle and rotation mechanism,according to many embodiments.

FIG. 10b shows a magnified view of the rotating face plate of the LeadHandle of FIG. 10 a.

FIG. 10c shows a section view of a Lead Handle and rotation mechanism,according to many embodiments.

FIG. 10d shows a magnified view of the rotation mechanism of FIG. 10 c.

FIG. 11a shows a perspective view of the Distal Lead Segment of anelectrical sensing/stimulation device, with the Tissue AttachmentMembers deployed from a common port to be separated from one another byabout 90°, according to many embodiments.

FIG. 11b shows a perspective view of the Distal Lead Segment of anelectrical sensing/stimulation device, with the Tissue AttachmentMembers deployed from a common port to be separated from one another bygreater than 90°, according to many embodiments.

FIG. 11c shows a perspective view of the Distal Lead Segment of anelectrical sensing/stimulation device, with the Tissue AttachmentMembers deployed from a common port to be separated from one another byless than 90°, according to many embodiments.

FIG. 11d shows the Tissue Attachment Member Assembly of FIGS. 11a to 11c.

FIG. 11e shows a side view of the Distal Lead Segment of an electricalsensing/stimulation device with Tissue Attachment Members orientedtoward the Lead Body, according to many embodiments.

FIG. 11f shows a front view of the Distal Lead Segment of FIG. 11 e.

FIG. 12a shows a perspective view of the Distal Lead Segment of anelectrical sensing/stimulation device, with the Tissue AttachmentMembers deployed from a common port to be axially/longitudinallyseparated but coplanar, according to many embodiments

FIG. 12b shows a perspective view of the Distal Lead Segment of anelectrical sensing/stimulation device, with the Tissue AttachmentMembers deployed from a common port and having a decreasing end loopradius, according to many embodiments.

FIG. 12c shows a perspective view of the Tissue Attachment MemberAssembly of an electrical sensing/stimulation device, with the TissueAttachment Members having end loops which decrease in radius along theirlength, according to many embodiments.

FIG. 13a shows a perspective view of the Distal Lead Segment of anelectrical sensing/stimulation device, with the Tissue AttachmentMembers deployed from an elongated common port and translated to thedistal end of the port, according to many embodiments.

FIG. 13b show a perspective view of the Distal Lead Segment of FIG. 13a, with the Tissue Attachment Members translated to the proximal end ofthe port.

FIG. 14 shows a perspective view of the Distal Lead Segment of anelectrical sensing/stimulation device, with the Tissue AttachmentMembers deployed from an elongated common port and having straightenedends, according to many embodiments.

FIG. 15a shows a perspective view of the Distal Lead Segment of anelectrical sensing/stimulation device, with the Tissue AttachmentMembers deployed from an elongated common port and comprising a hollowtube, according to many embodiments.

FIG. 15b shows a perspective view of the Distal Lead Segment of FIG. 15awhere helical anchor wires are deployed from the deployed TissueAttachment Members.

FIG. 15c shows a perspective view of the Distal Lead Segment of FIG. 15awhere the helical anchor wires are deployed and the Tissue AttachmentMembers are retracted.

FIG. 16a shows a section view of the Distal Lead Segment of anelectrical sensing/stimulation device introduced into a heart ventricle,with large-diameter biasing loops deployed, according to manyembodiments.

FIG. 16b shows a section view of the Distal Lead Segment of FIG. 16a ,with large-diameter biasing loops deployed and anchor-wires extendingfrom the loops.

FIG. 16c shows the large biasing loops and anchor-wires of FIG. 16 a.

FIG. 17a shows a “keyed” Tissue Attachment Member Assembly, according tomany embodiments.

FIG. 17b shows the “keyed” Tissue Attachment Member Assembly of FIG. 17aand the Distal Lead Segment of an electrical sensing/stimulation device.

FIGS. 18a, 18b, 18c, 18d, 18e, 18f, 18g, 18h, and 18i show variousDistal Tips of the Distal Lead Segment having integrated electrode(s),according to many embodiments.

FIG. 19a shows a cross-section of the apex of a patient's heart.

FIG. 19b shows a cross-section of the right ventricle taken from line19B-19B in FIG. 19 a.

FIG. 19c shows a section view of a Distal Lead Segment of an electricalsensing/stimulation device with a shaped Expandable Displacement Memberexpanded and conforming to the shape of the cavity of the rightventricle, according to many embodiments.

FIG. 19d shows a section view of the Distal Lead Segment of FIG. 19cwith the Expandable Displacement Member collapsed.

FIG. 19e shows a side view of the Distal Lead Segment of FIG. 19c withthe Expandable Displacement Member collapsed.

FIG. 19f shows a section view of the Distal Lead Segment of FIG. 19cwith the Expandable Displacement Member expanded.

FIG. 19g shows a side view of the Distal Lead Segment of FIG. 19c withthe Expandable Displacement Member expanded.

FIG. 19h shows a section view of the Distal Lead Segment of FIG. 19cwith the shaped Expandable Displacement Member expanded, showing howvarying the wall thickness of the Expandable Displacement Member inspecific locations can result in a desired shape when expanded.

FIG. 20a shows a section view of the Distal Lead Segment of anelectrical sensing/stimulation device with the Expandable DisplacementMember collapsed into a circle shape within the Lead Body, according tomany embodiments.

FIG. 20b shows a section view of the Distal Lead Segment of anelectrical sensing/stimulation device with the Expandable DisplacementMember collapsed into a C-shape within the Lead Body, according to manyembodiments.

FIG. 20c shows a section view of the Distal Lead Segment of anelectrical sensing/stimulation device with the Expandable DisplacementMember collapsed into an involuted C-shape, where the ends of the “C”involute within the “C”, and with the balloon nested within the LeadBody, according to many embodiments.

FIG. 20d shows a section view of the Distal Lead Segment of anelectrical sensing/stimulation device with the Expandable DisplacementMember collapsed into a spiral shape within the Lead Body, according tomany embodiments.

FIG. 20e shows a section view of the Distal Lead Segment of anelectrical sensing/stimulation device with the Expandable DisplacementMember collapsed into a serpentine shape within the Lead Body, accordingto many embodiments.

FIG. 21a shows a side view of the Distal Lead Segment of an electricalsensing/stimulation device with the Expandable Displacement Membercollapsed in the axial direction within the Lead Body, according to manyembodiments.

FIGS. 21b and 21c show side views of the Expandable Displacement Memberof FIG. 21a partially expanded outward and showing its axial fold.

FIG. 22a shows a side view of a serpentine marker for the ExpandableDisplacement Member of the Distal Lead Segment of an electricalsensing/stimulation device in a collapsed configuration, according tomany embodiments.

FIG. 22b shows a side view of the serpentine marker of FIG. 22a in anexpanded configuration.

FIG. 22c shows a side view of the serpentine marker of FIG. 22a mountedon the Expandable Displacement Member, both in their collapsedconfiguration.

FIG. 22d shows a top view of the serpentine marker of FIG. 22a mountedon the Expandable Displacement Member, both in their collapsedconfiguration.

FIG. 22e shows a side view of the serpentine marker of FIG. 22a mountedon the Expandable Displacement Member, both in their expandedconfiguration.

FIG. 22f shows a top view of the serpentine marker of FIG. 22a mountedon the Expandable Displacement Member, both in their expandedconfiguration.

FIG. 22g shows a side view of an arrow-shaped serpentine marker for theExpandable Displacement Member of the Distal Lead Segment of anelectrical sensing/stimulation device in a collapsed configuration,according to many embodiments.

FIG. 22h shows a side view of the arrow-shaped serpentine marker of FIG.22g in an expanded configuration.

FIG. 22i shows a top view of the arrow-shaped serpentine marker of FIG.22g mounted on the Expandable Displacement Member, both in theirexpanded configuration.

FIG. 22j shows a top view of the arrow-shaped serpentine marker of FIG.22g mounted on the Expandable Displacement Member, both in theircollapsed configuration

FIG. 23a shows a side view of the Distal Lead Segment of an electricalsensing/stimulation device with a Mechanically Expandable DisplacementMember in a collapsed configuration, according to many embodiments.

FIG. 23b shows a side view of the Distal Lead Segment of the electricalsensing/stimulation device of FIG. 23a with the Mechanically ExpandableDisplacement Member in an expanded configuration.

FIG. 23c shows a section view of the Distal Lead Segment of theelectrical sensing/stimulation device of FIG. 23a taken through line23C-23C in FIG. 23 b.

FIG. 24a shows an electrical sensing/stimulation device and an externalpower generator which may be coupled thereto, according to manyembodiments.

FIG. 24b shows an electrical sensing/stimulation device and an externalpower generator which may be coupled thereto through a magneticconnection hub, according to many embodiments.

FIG. 24c shows the electrical sensing/stimulation device, the externalpower generator, and the magnetic connection hub of FIG. 24b coupledtogether.

FIG. 25a shows a top view of an electrical sensing/stimulation device,an external power generator, and a retractable extension cord adapter,according to many embodiments.

FIG. 25b shows a top view of the retractable extension cord adapter ofFIG. 25a in an axially retracted configuration.

FIG. 25c shows a top view of the retractable extension cord adapter ofFIG. 25a in an axially stretched configuration.

FIG. 25d shows a top view of the retractable extension cord adapter ofFIG. 25 a.

FIG. 25e shows a side view of the retractable extension cord adapter ofFIG. 25 a.

FIG. 25f shows an exploded, side view of the retractable extension cordadapter of FIG. 25 a.

FIG. 25g shows a top view of an electrical sensing/stimulation devicewith an integrated retractable extension cord and an external powergenerator, according to many embodiments.

FIG. 26a shows a schematic, based on the detection of electrical currentchanges, for detecting movement of the Tissue Attachment Members of anelectrical sensing/stimulation device, according to many embodiments.

FIG. 26b shows another schematic, based on electrical current changes,for detecting movement of the Tissue Attachment Members of an electricalsensing/stimulation device, according to many embodiments.

FIG. 26c shows a side view of the LCD display of a Handle of anelectrical sensing/stimulation device capable of detecting movement ofthe Tissue Attachment Members, according to many embodiments.

FIG. 26d shows a side view of the LED display of a Handle of anelectrical sensing/stimulation device capable of detecting movement ofthe Tissue Attachment Members, according to many embodiments.

FIG. 26e shows a schematic of the circuitry of the handle of FIG. 26d ,and from the electrical current sensing elements of FIGS. 27a and 27 b.

FIG. 27a shows a perspective view of the Distal Lead Segment of anelectrical sensing/stimulation device with a Torque Control Member, anddecoupled shapeable member, according to many embodiments.

FIG. 27b shows a magnified view of the Torque Control Member of FIG. 27a.

DETAILED DESCRIPTION

The present disclosure describes herein devices and methods for thedelivery and affixation of an electrode, or an electrode array within abody cavity. Such an electrode or electrode array may be commonlyreferred to as a sensing or pacing lead. Such leads are described hereinfor use in cardiac applications, i.e., placement of the electrode orelectrode array within a chamber of the heart. But the devices andmethods described herein are not so limited, and may be applied to anycavity or vessel of the body accessible by way of a catheter system.Vascular access sites for introduction of the lead may be from theinternal jugular vein, femoral vein, or subclavian vein as examples, butare not so limited. The electrode, or electrode array may be used forsensing intrinsic electrical activity of body tissues, but the electrodeor electrode array may also be used to deliver electrical stimulation tothe body tissue when the electrode or electrode array is connected toeither an implanted electrical pulse generator (for example, via anadapter that may connect to the proximal pin connectors of the leadssuch as with industry standard IS-1 type connectors or the like) or anexternal electrical pulse generator.

FIGS. 1a and 1b show the fundamental elements of the lead distal segment100, which may include an elongate lead body 120, a displacementmechanism comprising an eccentrically expandable displacement element320 (that is, the expandable displacement element 320 may expand outlaterally from one lateral side of the elongate lead body 120, which maybe tubular in shape), sensing/stimulation electrode(s) 131 and 132,tissue attachment member(s) 141 and 142, and an atraumatic tip 110. Insome embodiments, the lead body 120 may have a nominal diameter of0.080″, and a working length (as measured along the lead body from thedevice distal tip to the handle) of 110 cm, but both are not so limitedand may be adjusted to suit any specific anatomical configuration. Asdescribed herein, each element of the lead may take on various designsand forms, but all operating in a fashion to provide the lead with thesame fundamental operational features. In some embodiments, element 142may exit the elongate body from the same location as 141, or vice aversa. Moreover, in some embodiments, one or more tissue attachmentmembers may exit the elongate body 120 from the same axial location.

Lead Body

The lead body 120 may comprise an extruded thermoplastic polymermaterial having one or more lumens. In some embodiments, the materialmay be Pellethane® having a Shore hardness of 55D or 63D, but is not solimited. A thermoset polymer such as silicone may also be used. Thepolymer may include a radiopaque additive such as barium sulfate orbismuth, such as to provide a fluoroscopic image of the lead body whenthe device is being imaged during the implantation procedure, using afluoroscope. FIGS. 2a-2c show the lead body 120 incorporating one ormore lumens that are used for communication from the proximal end of thelead body to the distal end of the lead body. In some embodiments, oneor more lumens communicate to the displacement member(s) 320, to theelectrode(s) 131, 132 and to the tissue attachment member(s) 141, 142.The distal end of the lead body may have a curve which may bemanipulable by the user and may terminate with an atraumatic tip 600 oranother atraumatic tip, examples of which are shown in FIGS. 8a-8d and18a -18 i.

Torque Control Member

Depending on the durometer and exact cross sectional profile of the leadbody, the lead body may or may not have the adequate torque controlrequired to align the distal lead segment 100 to the target tissueduring the implantation procedure. To provide increased torque controlto the lead body 120, a torque control member 710, 720, 730 may befabricated into the lead body 120. As depicted in FIGS. 6c, 7a, and9a-9c , within the length of the main central lumen 220 of the lead body120 may reside a torque control member 710, 720, 730. The torque controlmember may comprise a counter-wound coil configuration, wherein a firstinner coil 712 which is wound in a first direction is encased by anouter coil 714 that is wound in the opposite direction. These coilconfigurations can also be referred to as a “bi-plex” type coilassembly. This coil assembly can generally provide somewhat bettertorque control as the assembly is torqued in a direction that willtighten the outer coil onto the inner coil. Another coil configuration720, referred to as a “tri-plex” type coil assembly may include a thirdcoil 722, such that the inner and outer coils are wound in the samedirection, and the middle coil is wound in the opposite direction.Generally, a tri-plex coil assembly can provide better torque control asthe coil is rotated about its axis in either direction. A third type oftorque control member 730 is shown in FIG. 9c and may be a braidedcatheter shaft, a composite structure well known in the medical deviceindustry comprising an inner layer of polymer such as Pellethane ornylon but not so limited, surrounded by a braided tube consistingtypically of stainless steel wire, and then encased in an outer layer ofpolymer such as Pellethane or Nylon. Many suitable polymers may bespecified for the inner and outer layers and may also include polyimide,silicones or other thermoplastics or thermoset polymers. The braid wiremay be other than stainless steel, for example Nitinol, MP35N or 35NLT(available, for example, from Fort Wayne Metals, Fort Wayne, Ind.) orother appropriate metals or polymers such as Kevlar, but not so limited.The diameter of the braid wire may vary between 0.001″ and 0.010″, butis not so limited.

The bi-plex coil assembly 710, tri-plex coil assembly 720 or braidedcatheter shaft 730 may be inserted within and affixed within the maincentral lumen 220 by thermally melting the lead body material 120 intothe torque control member 710, 720 or 730, by adhesives, or co-extrudingthe lead body with the braid, but the attachment scheme is not solimited. The attachment to the main central lumen 220 may be in avariety of locations, such as along the entire length of the lead body120, at periodic intervals within the lead body, or at specificpredetermined points along the lead body 120. Affixing the torquecontrol member 710, 720 or 730 to the main central lumen 220 of the leadbody 120 can unify them to move as one assembly. The proximal end of thelead body 120 and the proximal end of the torque member 710, 720 or 730both terminate together and can be attached to the distal segment of thehandle. Thus, as the handle is rotated the torque member 710, 720 or 730and the lead body 120 can move in unison. Further torque members andtorque control members are described below and herein.

Displacement Member

The main central lumen 220 of the lead body 120 may terminate distallyat the displacement member 320. The main central lumen 220 of the leadbody 120 may travel within the length of the lead body and terminatesproximally at an inflation port 802 to allow connection of a device topressurize air or other inflation medium within the lumen 220 and theinflatable displacement member 320.

As shown in FIGS. 1b, 3a-3c, and 4a-4d , the displacement member maycomprise an expandable member 320 that may be mounted substantiallywithin the main central lumen 220 of the lead body 120. This expandabledisplacement member 320 may generally comprise a tubular structure(tube) and may be constructed of an elastomeric polymer, a thin-wallednon-compliant or semi-compliant polymer. The expandable displacementmember 320 may be inflated to expand the displacement member 320 in manyembodiments. When inflated with air, CO₂, liquid (e.g. water, iodinatedcontrast/water solution, or other appropriate biocompatible fluid), orother inflation medium, the inflatable displacement member 320 willexpand and deploy through the deployment window 210 that is cut into thecentral main lumen 220 of the lead body 120. Being that the expandabledisplacement member 320 can deploy through a deployment window 210 onone side of the lead body, the expansion of the expandable displacementmember 320 may be eccentric to the lead body 120 itself. The position ofthe deployment window 210 can be substantially opposite (for example,diametrically opposing or on opposite lateral sides) to that of thetissue attachment member deployment ports 240, but the deployment window210 may be positioned at any angular position as well as any axialand/or longitudinal position relative to the tissue attachment memberdeployment ports 240. In some embodiments, two or more tissue attachmentmembers 141, 142 may be deployed from one tissue member deployment port240. In some embodiments, the displacement member 320 may compriseexpandable metal or polymeric scaffoldings, i.e., tubular meshes as anexample that when foreshortened along their axis may radially expand.Other examples of expandable members are shown in U.S. patentapplication Ser. No. 13/219,874 to Garai, et al, the contents of whichare fully incorporated herein by reference.

In some embodiments, the expandable displacement member 320 may be anelastomeric polymer material. Other suitable materials may be used thatcan afford the degree of expansion as required by the size and shape ofthe anatomical structure within which the lead will be positioned andaffixed to the tissue. When inflated, the expandable displacement member320 can expand and deploy through the deployment window 210, and whendeflated the expandable displacement member 320 can contract and resumeits mounted position within the main central lumen 220 of the lead body120. When properly positioned in a body cavity, expansion of theexpandable displacement member 320 can initiate contact and exert forceon a wall of a body cavity, thus displacing the lead body 120,associated electrode(s) 131, 132, and tissue attachment deployment ports240 in a different (e.g., the opposite) direction, towards the tissuetargeted for contact with the electrode(s) 131, 132, and to orient thetissue attachment deployment ports 240 to also be opposed to the targettissue for deployment of the tissue attachment member(s) 141, 142 intothe target tissue for affixation to the tissue. The expandabledisplacement member 210 may also be constructed of a non-compliant orsemi-compliant polymer or other material suitable for inflation. In thisconfiguration, the expandable displacement member 320 may be folded in afashion to allow its placement substantially within the lead body, andupon deflation the inflatable displacement member may re-fold andretract back to its original un-deployed configuration.

As shown in FIGS. 3a-3c , the expandable displacement member 320 can bemounted over a hollow D-shaped longitudinal element 310, which may be acoil, polymer extrusion or injection molded component, as examples. Asshown in FIG. 3a , when mounted in this fashion, the D-shapedlongitudinal element and the expandable displacement element 320 form acartridge 300. In this configuration, the circumference of the outerdiameter of the expandable displacement member 320 will be less than thecircumference of the inner diameter of the lumen 220 within which theexpandable displacement member 320 resides. The expandable membercartridge 300 can be inserted into the distal end of the central mainlumen 220, positioned central to the deployment window 210, and affixedin place at the proximal and distal ends within the central main lumen220 using adhesives or thermal bonding. The proximal end of thecartridge may be open and can be in communication with the main centrallumen 220 of the lead body 120, and is thus inflated as describedearlier.

As shown in FIGS. 4a-4c , the expandable displacement member 420 mayalso comprise a tubular structure (tube) and may be fabricated usingsimilar materials as those in described above with reference to FIG. 3a. However, in the embodiments shown in FIGS. 4a-4c , the expandabledisplacement member 420 may be folded onto itself and configured in a“C-shaped” nested configuration. An advantage of this configuration isthat for a given lumen 410 within which the expandable displacementmember 320 resides, the circumference of the tube which is folded toproduce the nested configuration can be greater than the innercircumference of the lumen 410. Given the same materials and wallthickness of the tube to make the expandable displacement members 320and 420, upon expansion the expandable displacement member 420 of FIG. 4can be capable of expanding more than the expandable displacement member320 as shown in FIG. 3, due to the fact that the effective circumferenceof the expandable displacement member 420 is greater than that of theexpandable displacement member 320.

The configuration of mounting the expandable displacement member 320 or420 within a lumen 220 of the lead body 120 can allow the expandablemember 320, 420 to deploy through the deployment window 210. Thelongitudinal and circumferential dimensions of the deployment window 210may be adjusted as deemed appropriate to control the deployed dimensionsof the displacement member, for example by controlling the volume of airor fluid within the expandable displacement member, consistent with theanatomical requirements within which the lead may be designed tooperate. Lengthening the deployment window 210 can thus increase thelength of the deployed displacement member 320, 420, while increasing ordecreasing the circumferential dimension of the deployment window canincrease or decrease the amount of expansion, and thus the diameter, ofthe expandable displacement member 320, 420. Inflation of the C-shapedfolded expandable displacement member 420 can be accomplished via asmall communication tube 425, the distal end of which lies within thelumen of the expandable displacement member 420 and the proximal end ofwhich is in communication with the main central lumen 220 of the leadbody 120. Both ends of the C-shaped balloon may be sealed to provide ahermetically inflatable balloon cartridge. Additionally, thecommunication tube 425 may be sealed to the distal end of at least oneembodiment of the torque member 730 such that the torque member 730 canalso serve the purpose of the inflation lumen for the balloon cartridge.In this instance, the torque member 730 may be a polymer laminated shaftof braided stainless steel wire, coil, or similar structure and wouldhave a continuous wall structure capable of holding pressure.

FIGS. 20a to 20e show section views of the distal lead segment 100 ordistal lead segment 100 a (discussed further below and herein). As shownin FIGS. 20a to 20e , the expandable displacement element 320 may befolded in different ways within the body of the distal lead segment 100or 100 a.

As shown in FIG. 20a , the expandable displacement element 320 may becircular or elliptical when collapsed within the distal lead segment 100or 100 a. The expandable displacement element 320 may have acircumference 326 a which is smaller than that of the distal leadsegment 100 or 100 a, which may limit the size of the expandabledisplacement element 320 when expanded at least partially out of theexit port 324 of the distal lead segment 100 or 100 a.

FIGS. 20b to 20e show examples of other ways to nest the expandabledisplacement element 320 within the distal lead segment 100 or 100 a,such to increase the circumference of the expandable displacementelement 320 such that the expandable displacement element 320 can have agreater size when expanded at least partially out of the exit port 324of the distal lead segment 100 or 100 a.

As shown in FIG. 20b , the expandable displacement element 320 may befolded into a C-shape when collapsed within the distal lead segment 100or 100 a and may have a circumference 326 b which may be greater thanthe circumference 326 a and/or the circumference of the distal leadsegment 100 or 100 a. As shown in FIG. 20c , the expandable displacementelement 320 may be folded into an involuted C-shape (that is, the endsof the “C” involute) when collapsed within the distal lead segment 100or 100 a and may have a circumference 326 c which may be greater thanthe circumference 326 a and/or the circumference of the distal leadsegment 100 or 100 a. As shown in FIG. 20d , the expandable displacementelement 320 may be folded into a spiral shape when collapsed within thedistal lead segment 100 or 100 a and may have a circumference 326 dwhich may be greater than the circumference 326 a and/or thecircumference of the distal lead segment 100 or 100 a. As shown in FIG.20e , the expandable displacement element 320 may be folded into aserpentine shape when collapsed within the distal lead segment 100 or100 a and may have a circumference 326 e which may be greater than thecircumference 326 a and/or the circumference of the distal lead segment100 or 100 a. In the embodiments shown by FIGS. 20a to 20e , theinflation medium 322 may be provided inside the expandable displacementelement 320 within the distal lead segment 100 or 100 a while ambientfluid such as blood may reside outside of the expandable displacementelement 320.

FIGS. 20b to 20e show that the expandable displacement element 320 maybe folded about the axial or longitudinal axis of the distal leadsegment 100 or 100 a. Alternatively or in combination, the expandabledisplacement element 320 may be folded in a direction transverse to theaxial or longitudinal axis of the distal lead segment 100 or 100 a asshown in FIGS. 21a to 21c . FIG. 21a shows the expandable displacementelement 320 fully collapsed within the distal lead segment 100 or 100 a.FIGS. 21b and 21c show the expandable displacement element 320 partiallyexpanded and exposing the folded portion of the expandable displacementelement 320.

As shown in FIGS. 5a-5e , the expandable displacement member 526 maycomprise a generally tubular structure fabricated of similar materialsmentioned for the embodiments in FIGS. 3 and 4. FIG. 5 may demonstratethat the tubular expandable displacement member 526 may be mounted in aspiral, or helical fashion on a cartridge 500. The cartridge 500 mayhave distal and proximal receiving channels 502, 504 for receiving andmounting of the distal and proximal ends of the expandable displacementmember 526. Mounting can be performed by use of adhesives, or thermalboding, but is not so limited. The expandable displacement member 526may be inflated via a small port 506 at the proximal end of the mountingcartridge 500 that communicates between the lead lumen 220 to theinterior of the expandable displacement member 526. The length of theexpandable displacement member 526 held between the distal and proximalbonding areas 502 and 504 can thus comprise the expandable portion ofthe member that extends through the deployment window 210 of the leadbody 120. An advantage provided by such an expandable displacementmember 526 is that for a given size lead body 120 and deployment window210, the diameter of the expandable displacement member 526 tube can beincreased beyond those of FIGS. 3 and 4. FIG. 5e shows that thelongitudinal axis of the expandable displacement member 526 tube is atan angle θ to that of the lead body axis. FIG. 5c shows the width “d” ofthe expandable displacement member 526 tube, when flattened and mountedon the cartridge 500. By adjusting the angle θ and the length of thedeployment window 210, the width of the flattened expandabledisplacement member 526 tube, and accordingly the tube's diameter, canbe increased to afford even greater expansion of the expandabledisplacement member 526.

The aforementioned displacement members 320, 420, and 520 can generallybe considered as a single lumen tube. However, it can be appreciatedthat any of these displacement members may be sub-divided such that asseen in cross-section, there may be multiple parallel lumens. One suchexample is shown in cross section in FIG. 3a ′ wherein two or morelumens 330 may be coincident along the length of the displacementmember. FIG. 3a ′ shows the cross section of the displacement member 325in the un-inflated state, and FIG. 3a ″ shows the displacement member inthe inflated state. In this configuration, the displacement member mayor may not be mounted on a cartridge. The inflation member may simply beinserted into the lead body extrusion 220 and affixed in place with thislumen using methods previously described. Under inflation, each lumenmay inflate and a specific cross-sectional geometric configuration maybe produced as shown in FIG. 3″. Thus, a shape that closely matches theanatomical cavity within which the displacement member is inflated maybe produced, such that the inflated displacement member may self-alignto the anatomical space.

The expandable displacement member 320, 420, or 520 may also incorporatefluoroscopic indicators printed on its surface, as expandable markers,or as local markers. In the case of an expandable marker, as theexpandable displacement member 320, 420, or 520 expands, the printedfluoroscopic markers can elongate with the expansion of the displacementmember 320, 420, or 520, forming an elongate marker. Alternatively or incombination, the marker may be printed as a serpentine shape, and maytransform into a more linear shape as the expandable displacement member320, 420, or 520 expands. In other embodiments, the fluoroscopicindicators may simply be small local points, such that as the expandabledisplacement member 320, 420, or 520 expands the local printed pointsmove with the displacement member 320, 420, or 520. Having local pointsprinted on one side of the displacement member 320, 420, or 520, forexample, may give a fluoroscopic indicator as to the alignment of thedistal lead segment 120 within the body cavity. Pad printing of tungstenmarkers or other radiopaque materials may be used in fabricating thesetypes of markers.

As shown in FIGS. 22a to 22j , the expandable displacement member 320may comprise a metallic film or radiopaque marker 328 to help guide thedistal lead segment 100 or 100 a. The marker 328 may have a shape suchthat it can expand as the expandable displacement member 320 expands andcollapses as the expandable displacement member 320 collapses. Forexample, the marker 328 may have a serpentine pattern. The marker 328may comprise fillets on one or more of its corners to allow theserpentine patterned marker 328 to expand and collapse with minimalinternal stress or strain such that it does not break or tear as themarker 328 cycles between expansion and collapse.

FIG. 22a shows an exemplary marker 328 having a serpentine pattern andin the collapsed configuration. When an axially or radially expansiveforce 328 a is applied, the marker 328 can axially and/or radiallyexpand as shown in FIG. 22 b.

FIGS. 22c and 22d show the marker 328 placed over the outer surface ofthe expandable displacement member 320. The expandable displacementmember 320 is shown to be in the collapsed configuration with the marker328 collapsed. FIGS. 22e and 22f show the expandable displacement member320 in the expanded configuration with the marker 328 expanded.

In some embodiments, the marker 328 may have a serpentine pattern suchthat when expanded, the marker 328 can form a specific shape, such as anarrow, to help the user better orient the distal lead segment 100 or 100a under fluoroscopic guidance. FIG. 22g shows an exemplary, arrow-shapedmarker 328 in a collapsed configuration and FIG. 22h shows thearrow-shaped marker 328 in the expanded configuration under expansiveforces 328 a. FIG. 22i shows the arrow-shaped marker 328 mounted on theexpandable displacement member 320 which is expanded, thereby expandingthe arrow-shaped marker 328. FIG. 22j shows the arrow-shaped marker 328mounted on the expandable displacement member 320 which is collapsed,thereby collapsing the arrow-shaped marker 328.

The expandable displacement element 320, 420, and 520 may be configuredin further various ways for various uses and advantages. As shown inFIGS. 19a to 19h , the expandable displacement element 320 may be shapedto conform to the shape of a target body cavity when expanded. Forexample, the expandable displacement element 320 when expanded may havea shape conforming to that of the right ventricle RV. The expandabledisplacement elements 420 and 520 may also be configured to have a shapewhen expanded to conform to the shape of the target body cavity.

FIGS. 19a and 19b show the anatomy of the apex of the heart, includingthe right ventricle RV, left ventricle LV, the interventricular septumIVS separating the right ventricle RV with the left ventricle LV, andthe free wall FW of the right ventricle RV. FIG. 19b shows across-section of the heart taken through line 19B.

FIG. 19c shows the sensing/stimulation device distal lead segment 100 or100 a introduced into the right ventricle RV. The expandabledisplacement element 320 may be expanded with an inflation medium 322and may have an ovoid or elliptical cross-sectional shape when expandedto match the cross-sectional shape of the cavity of the right ventricleRV. The inflation medium 322 may comprise one or more of saline, water,buffer, air, gaseous CO₂, to name a few.

FIGS. 19d and 19e show the device distal lead segment 100 or 100 a withthe expandable displacement element 320 collapsed. FIGS. 19f and 19gshow the device distal lead segment 100 or 100 a with the expandabledisplacement element 320 expanded. FIG. 19e shows a side-view of thedevice distal lead segment 100 or 100 a and FIG. 19d shows a sectionview of the distal lead segment 100 or 100 a taken through line 19D-19D.FIG. 19g shows a side-view of the device distal lead segment 100 or 100a and FIG. 19f shows a section view of the distal lead segment 100 or100 a taken through line 19F-19F.

FIG. 19f shows the sensing/stimulation device distal lead segment 100 or100 a with the expandable displacement element 320 expanded. To achievethe desired shape upon expansion, the expandable displacement element320 may comprise greater thickness wall areas 320 a and lesser thicknesswall areas 320 b. The greater thickness wall areas 320 a may bediametrically opposed (180 degrees) from one another. The lesserthickness wall areas 320 b may be diametrically opposed (180 degrees)from one another. The lesser thickness wall areas 320 a may have apropensity to expand under lower pressures than the greater thicknesswall areas 320 a. Accordingly, the expandable displacement element 320may expand to an ovoid or elliptical shape in cross-section whenexpanded or inflated. When expanded or inflated, the expandabledisplacement element 320 having such a shape can provide a backing forceto the stabilizers (e.g., stabilizers or deployment members 141/141 a,142/142 a, 141 b, 142 b, 141 d, 142 d) and can also self-align thedistal lead segment 100 or 100 a into the right ventricular pocket. Theexpandable displacement element 320 may be made from an extrusion tohave such greater thickness wall areas 320 a and lesser thickness wallareas 320 b.

As discussed above and herein, the expandable displacement member 320may be an inflatable element which may be inflated with an inflationmedium. Alternatively or in combination, the distal lead segment 100 or100 a may comprise a mechanical expander 320 a which may comprise amalecot, an expandable cage, or an expandable scaffold biased to be inan expanded configuration. For example, the mechanical expander 320 amay comprise a slotted tube made of a shape memory material such asNitinol, and the mechanical expander 320 a may have an inner lumenthrough which a shaft can be advanced to push the distal segment 100 outrelative to the lead body 120 to contract the mechanical expander 320 a.FIG. 23a shows, for example, a force 2301 exerted to place themechanical expander 320 a in the collapsed configuration. FIG. 23bshows, for example, the mechanical expander 320 a in the expandedconfiguration with anchors 2303 expanded radially outward to deployanchors 2305 through anchor ports 2307 and radially extend electrodes2309. The mechanical expander 320 a may comprise a plurality ofconductive tubes 2313 with electrically insulated surface portions 2311and surface portions which are not electrically insulated and comprisethe electrodes 2309. FIG. 23c shows a cross-section of the distal leadsegment 100 or 100 a with the mechanical expander 320 a taken from line23C-23C in FIG. 23b . As shown in FIG. 23c , the tubes 2313 may extendthrough the lead body 120 and may have inner lumens through which theanchor wires 2305 may pass through.

Tissue Attachment Members

As shown in FIGS. 6a, 6a ′, and 6 b, each tissue attachment member(s)141, 142 may comprise metallic, elastic, superelastic, or shape-memorywire or tube, the distal end of each wire or tube having a formed loopthat is capable of being straightened, and then reformed. The diameterof each wire or tube may range from 0.005″ to 0.015″, but is not solimited. As shown in FIGS. 6a and 6b , the tissue attachment member(s)141, 142 may be attached side by side, at the region labeled 145 vialaser welding, resistance welding, crimping (using a crimp tube), or byadhesive. In this region 145, the tissue attachment members may be keyedin the oblong-shaped lumen 222 such that they may not rotate in thelumen, and thus this “keying” (providing an interference fit between adriving and a following member) allows forward-backward translation ofthe tissue attachment member assembly 140. Vias or ports 240 may be cutthrough the lead body outer wall and into lumen 222 through which thetip and distal segment of the tissue attachment member(s) 141, 142 aredeployed. As depicted in FIGS. 7a and 7b , it can be appreciated thatupon proximal retraction of the tissue attachment assembly 140, thedistal loop of each wire may assume a linear configuration when fullyretracted into the oval lumen 222. In this configuration, with thetissue attachment members retracted into the lead body, the lead can beadvanced through the appropriate vasculature or body chamber to thetarget destination.

As shown in FIG. 6a ′, the orientation of each tissue attachmentmember(s) 141′, 142′ may be reversed such that the tissue attachmentmember(s) 141′, 142′ are deployed through the deployment port 240 uponproximal retraction of the tissue attachment assembly 140′, andretracted into the oval lumen 222 to assume a linear configurations upondistal advancement of the assembly 140′. This configuration may be keyedwithin the oval lumen 222 in exactly the same manner as for tissueattachment assembly 140.

FIG. 4a shows a vertical orientation of the oval lumen 402 within whichthe tissue attachment member(s) 141, 142 are oriented. In thisconfiguration, it can be appreciated that the tissue attachmentmember(s) 141, 142 may be attached to each other in a verticalorientation, rather than a horizontal orientation.

Sensing/Stimulation Electrodes

As shown in FIGS. 1 and 7, the electrode(s) 131, 132 may be mountedsubstantially on the surface of the lead body 120, but may also beembedded within the lead body 120 such that the appropriate surface areaof the electrode(s) 131, 132 is exposed. The associated electrodeconductor wire(s) 520 may be joined to the electrode(s) 131, 132 vialaser welding, resistance welding or conductive adhesives. The conductorwire(s) 520 may pass from the electrode(s) 131, 132 through via(s) orport(s) 230 cut into the lead body 120 and into the electrode conductorwire lumen(s) 221. The electrode conductor wire(s) 520 may then runproximally along the length of the electrode conductor wire lumen(s) 221to the lead handle 800. Alternatively or in combination, the lumen 221may hold multiple electrode conductor wires 520. In this case, eachelectrode conductor wire 520 would require separate electricalinsulation.

The electrodes may be generally cylindrically-shaped to fit around theouter surface of the lead body 120. The profile of the electrode(s) maybe varied to provide a geometric shape such as a triangle, T-shape ortrapezoid, but these examples do not limit the shapes that can beproduced. The profile of the electrode can serve as a visual indicatorwhen aligning the distal segment of the lead body 100 to the targettissue. FIG. 7b ′ shows an example of the electrodes 131′, 132′configured to appear as a trapezoid when viewed under fluoroscopy. Theelectrodes 131′, 132′ can thus be mounted on the lead body 120 such thatas the device is torqued into proper position at the target tissue siteunder fluoroscopy, the electrodes will appear as trapezoids, andindicating that the tissue attachment member ports 240 are properlyaligned to the tissue to which the tissue attachment member(s) 141, 142will be deployed.

The electrodes may also be fabricated in a non-cylindrical shape, suchas a pad, disc, patch, linear member or a micro-array of pointelectrodes, all which may lie substantially on the surface of the leadbody. These geometries may provide a more focused interface to thetarget tissue, providing more accurate ability to sense lower-thresholdelectrophysiological signals, and to also provide higher currentdensities when stimulating tissue, by virtue of delivering an equalamount of stimulation current via a smaller surface area than that of aring electrode.

Atraumatic Tip

Referring to FIGS. 8a-8d , the lead distal segment 100 may alsoincorporate a distal atraumatic tip termination 600. The distal end ofthe main central lumen 220 may receive the proximal mounting inserts602, 603 of the distal atraumatic tip 600. Feature 602 may be sized andconfigured to fit precisely within the end of the main central lumen220, and the feature 603 may be sized and configured to fit within thelumen of the D-shaped element 310. Thus, the atraumatic tip may bejoined to the central main lumen 220 and the D-shaped element 310 usingadhesives, or by thermal joining, i.e., melting of these contact areas.The distal tip termination can also be configured as a small inflatableballoon 610. In this embodiment, the tip termination is hollow having athin-walled bulbous tip, with one section of the bulbous tip beingthicker 616, such that when the distal tip is inflated the balloon willexpand eccentrically. This eccentric expansion can allow the tip to restagainst the endocardial tissue in a very atraumatic fashion, but wheninflated cannot act to displace the lead body, electrodes, andattachment member exit ports away from the target tissue. The balloontip 610 may be inflated via the lead's main lumen 220, or may beinflated via a separate, dedicated lumen of the lead body 120.

As shown in FIGS. 18a to 18i , the lead distal segment 100 a may includeone or more tip electrodes. As shown in FIG. 18a , the lead distalsegment 100 a may have a tip that incorporates an integral “ball” or“spot” type electrode 1800 a, positioned at the very distal end of thelead tip 110, or may be positioned at any radial location along thelength of the tip 110. A very small diameter, flexible wire may beattached to the ball or disc electrode 1800 a by laser welding,crimping, conductive adhesive or other electrical attachment methodsknown in the art. This electrode 1800 a may serve the same stimulationfunction as the distal tip electrodes 131, 132, however since the “ball”or “spot” type electrode 1800 a resides at a location on thelow-durometer polymer atraumatic tip 110 of the lead distal segment 100a, and may be connected to a flexible wire, the tip 110 of the leaddistal segment 100 a can remain flexible and atraumatic. Anotheradvantage of the “ball” or spot electrode 1800 a as an integral part ofthe tip 110 may be to provide a fluoroscopic marker to indicate thedistal tip 110 position during implantation of the device 100 a.Alternatively, the “ball” 1800 a may not serve as an active electrode(no wire attached), but only for fluoroscopic imaging.

Other shapes for the atraumatic tip 110 are also contemplated. FIG. 18bshows a cobra-head atraumatic tip 1800 b, which may be foldable to allowintroduction into a sheath. FIG. 18c shows an elbowed tip 1800 c, whichmay be foldable to allow introduction into a sheath. FIG. 18d shows abilateral eccentric tip 1800 d. FIG. 18e shows a quad-eccentric tip 1800e.

In some embodiments, the lead distal segment 100 a may have a tip 110that is configured with rearward-facing angled tines 1800 f. The innerportion of each tine 1800 f may be outfitted with an electrode 1810 f.The tines 1800 f may engage the trabeculated tissue in the apical regionof the right ventricle RV, or other anatomical structures to provide a“passive fixation” of the lead's interface to the anatomy. Passivefixation may generally involve any feature of the device 100 a thataffixes to the tissue without any feature of the device 100 a actuallypenetrating the tissue to provide fixation. Passive engagement maygenerally be achieved by the inner portion of the tine 1800 f “hooking”around an anatomical feature such as trabecular bands, as are found inthe apical region of the ventricles. Thus, the electrode placement atthe inner aspect of each tine 1800 f can directly interface to theanatomical feature that the tine 1800 f has engaged.

Electrodes may also be placed at the distal end of each tine 1800 fand/or at the distal tip of the lead body 120 itself. Bipolar sensingand pacing can thus be achieved from a multitude of electrode pairs.Other features of the lead may be similar to those features describedabove and herein, e.g. the band electrodes, the tissue stabilizers andthe eccentric balloon. Any of these features many be used, or none maybe used in combination with the tines 1800 f.

“Satellite” type electrodes 1800 g may also be placed at various radialor circumferential locations about the lead tip 100 a or the lead body120, as shown in the FIG. 18g and 18h . Single or double “helix” typeelectrode configurations 1800 h may also be employed as shown in FIG.18i . A double-helix configuration may allow a bi-pole electrode to beestablished between the two helices; however, one or both helixelectrodes could also be used in conjunction with a ring-electrode toestablish various configurations of bi-poles. One helix of the doublehelix may comprise a positive electrode and the other helix may comprisea negative electrode.

Laser-cut hypotubes can also be micro-machined to provide a multitude ofelectrode shapes and numbers. An example is shown in FIG. 18i whereinlongitudinal electrodes 1800 i have been fabricated from the laser-cutmachining process.

Handle Assembly

The handle assembly 800 is shown in FIG. 10. The main components maycomprise an outer handle body 810, an inner sliding actuator 808, and ahandle faceplate 804. The proximal end of the lead body 122 may beattached to the handle faceplate using conventional joining methods suchas epoxy or UV-cure adhesive. The handle faceplate 804 may be in turnattached to the outer handle body 810 using similar joining techniques.Turning the handle assembly 800 about its axis can thus transmitrotational movement and torque to the lead body 120 via the torquecontrol member 710, 720 or 730. Alternatively or in combination, thelead body 120 may be rotated using a control member on the handleassembly 800 while the handle assembly remains stationary relative tothe lead body 120. Within the outer handle body 810 may be an innersliding actuator 808. The proximal end of the tissue attachment assembly140 may emerge from the proximal end of the lead body 122 and may beattached to the inner sliding actuator 808 using conventional joiningmethods such as epoxy or UV-cure adhesive. A finger or thumb-operatedknob 806, or other actuation mechanism, such as a switch, button,slider, or the like, can be mounted into the inner sliding actuator 808.The knob 806 may pass through a C-shaped channel 812 in the outer handlebody 810. When moved to its furthest proximal position in the channel,the tissue attachment members 141, 142 may be completely retracted intothe lead body, as shown in FIG. 7a . The knob 806 may then be moved, forexample, laterally, within the C-shaped channel 812 to lock the positionof the inner sliding actuator 808. To advance/deploy the tissueattachment members, the knob 806 may be moved laterally to thelongitudinal portion of the C-channel, and then advanced forward. Thisaction may deploy the tissue attachment members 141, 142. The knob 806may then be moved laterally within the C-shaped channel 812 to lock theposition of the inner sliding actuator 808 in the deployedconfiguration. The “C-shaped” channel 812 is but one template to guidethe movement of the knob 806 for the deployment, locking and retractionof the tissue stabilizers. Other such templates may be contemplated. Onesuch channel may comprise a be a “Z-shaped” channel wherein the top andbottom horizontal segments of the Z-shape are oriented perpendicular tothe axis of the handle body, and the terminal ends of the top and bottomhorizontal segments of the Z-shape may be used as lock positions for theknob 806. The knob 806 may translate along the diagonal portion of theZ-channel (connecting the top and bottom horizontal segments) to deployand retract the tissue stabilizers.

At the proximal segment of the lead body 122, a Y-adapter 801 may bemounted onto the lead body. The Y-adapter may be attached and sealed tothe lead body 122 at both proximal and distal ends. A small cutout inthe lead body and into the main lumen 220 allows communication of air orfluid from the Y-adapter port 802. This port may be configured as astandard type luer connector known commonly in the industry. SimilarY-adapters may be used as a directional conduit for the electrode wireto exit at the proximal region of the lead and terminate in a plug thatis used to connect the lead to the external pacemaker.

Referring now to FIGS. 10A to 10B, the handle faceplate 804 may be freeto rotate about the distal end of the handle. The handle faceplate 804may have a circumferentially raised ring 820 that locks into place witha mating circumferential groove or detent 822 in the distal innerdiameter of the handle body 810. To assemble, the handle faceplate 804may simply be pushed onto the handle body, thus “snapping” the two partstogether. A sufficient gap may be allocated in the mating of the raisedring 820 and the circumferential groove or detent 822 such that thehandle faceplate may rotate freely about the handle body.

Rotation of the handle faceplate 804 may rotate the lead body 120 due tothe connection between the faceplate 804 and lead body 120. As thehandle faceplate 804 and lead body are rotated, it may be desirable forthe proximal end of the tissue attachment assembly 140 to also freelyrotate within the internal handle shuttle 808, yet maintain capabilityto translate the tissue attachment assembly 140 distal and proximal todeploy and retract the tissue attachment members. This can preventwind-up of the proximal wire of the tissue attachment assembly 140.

Referring to FIGS. 10C and 10D, one way to provide this functionality isto capture the proximal end of the tissue attachment assembly 140 (wire)within a hypotube sleeve 810 that is affixed within the internal handleshuttle 808. The proximal end of the wire of the tissue attachmentassembly 140 may have circumferential raised features 150 that can befree to rotate within the hypotube sleeve 810, and the ends of thehypotube sleeve 810 may be crimped to a lesser diameter such that upondistal/proximal translation of the hypotube sleeve 810 and handleshuttle the circumferential features of the wire 150 will abut againstthe end-crimps of the hypotube sleeve, thus moving the wire 140distal/proximal, yet the proximal end of the tissue attachment assembly140 (wire) is free to rotate within the hypotube sleeve 810.

Orientation of Lead Body Towards Target Tissue

It is generally appreciated that the procedural alignment of the distalsegment of the lead body towards the target tissue may be greatlyfacilitated by the use of the torque control members in FIGS. 9a-9c .Other methods may also be employed such as using a preformedtwo-dimensional or three dimensional internal stylet positioned withinthe lead body, or shaping of the lead body itself. The stylet may bepermanently mounted within the lead body, or may be configured to beadvanced distally and retracted proximally as required during thedelivery and implantation of the lead. The stylet may also be configuredto be completely removable from the lead body once its use is completedin the implant procedure. In either case, the pre-shapes of the stylet,or the pre-shape of the lead body itself may be formed to follow andnaturally align to the anatomical pathway to the target tissue. As anexample, for delivery of the lead to the right ventricle of the heart,and via access through the internal jugular vein, a specific shape canbe set into either the stylet or lead body that conforms to the entranceinto the internal jugular vein, through the innominate vein, through thesuperior vena cava, through the right atrium, and into the rightventricle. This fundamental two-dimensional or three-dimensional pathwaymay be formed into the lead such that when the distal lead has beendelivered to the right ventricle the lead will be urged to “self-align”to this pathway. Further, the displacement member 320 can be orientedsuch that when the lead is “self-aligned” the displacement member 320will be substantially in the correct orientation within the rightventricle, also positioning the tissue attachment members 141, 142towards the target implantation site. These alignment techniques andembodiments may be used in conjunction with directional radiopaquemarker bands. Marker bands may also be used as a rotational indicator asdescribed earlier in the trapezoid shapes of the electrodes. Thetrapezoid is an example of an eccentric shape that when viewed underfluoroscopy may face in a unique direction. Incorporating the eccentricshape into an electrode is an example of how to embody the eccentricrotational marker, but the marker may be a separate full or partial bandfashioned with eccentric features.

The distal lead segment 100 may also be configured such that it isrotatable about the elongate lead body 120. In this configuration, theproximal end of the distal lead distal segment 100 may be rotatablyattached to the distal end of the elongate body 120, and the proximalend of the elongate body is connected to a rotatable face, or dial onthe handle, via an elongate rotatable member lying within the elongatebody 120. Thus, turning the dial or faceplate on the handle couples therotational movement to the distal lead segment 100, while the elongatelead body remains stationary and does not rotate.

Tissue Stabilizer Embodiments

As discussed above and herein, the tissue stabilizers or attachmentmembers 141 and 142 may be longitudinally separated and within the samedeployment “plane”. Alternatively or in combination, a plurality oftissue stabilizers or attachment members 141 a and 142 a may deploy froma common deployment port 230 a of the lead distal segment 100 a of thelead body 120. The tissue stabilizer or attachment member loops 141 aand 142 a may be separated by an angle from 0° to more than 180°. FIGS.11a-11d show tissue stabilizer or attachment member loops 141 a and 142a that are separated by 20° to 90°, although such ranges are notlimiting. FIGS. 11a to 11c show the tissue stabilizer or attachmentmember loops 141 a and 142 a extending from the common deployment port230 a. In FIG. 11a , the tissue stabilizer or attachment member loops141 a and 142 b are separated by about 90°. In FIG. 11b , the tissuestabilizer or attachment member loops 141 a and 142 b are separated bygreater than 90°. In FIG. 11c , the tissue stabilizer or attachmentmember loops 141 a and 142 b are separated by less than 90°. FIG. 11dshows the tissue attachment assembly 140 a comprising the tissuestabilizer or attachment member loops 141 a and 142 b alone. In someembodiments, each stabilizer 141 a or 142 a forms a loop of a constantradius. Alternatively or in combination, the tissue attachment members141 and 142 may face toward the surface of the distal lead body 100 or100 a as shown in FIGS. 11e and 11f . The tissue attachment members 141and 142 may initially face away from the surface of the distal lead body100 or 100 a before curving back toward the surface of the distal leadbody 100 or 100 a. In FIGS. 11e and 11f , the tissue stabilizer orattachment member loops 141 a and 142 b are separated by more than 180°,such as about 270°.

The attachment members or tissue stabilizers 141 and 142 may also beco-planar and exit from a common deployment port 230 a as shown in FIG.12a . The axial or longitudinal separation between the attachmentmembers or tissue stabilizers 141 and 142 may vary from 0.050″ to0.100″, but is not so limited. A point of separation may be reachedwherein the stabilizers no longer overlap and are actually “separated”from each other. In such cases, a common deployment port 230 a (as inFIG. 12a ) or separate deployment ports 230 may be utilized.

As discussed above and herein, two tissue stabilizers or attachmentmembers 141/141 a and 142/142 a are deployed. However, the number oftissue stabilizers or attachment members may be increased to 3, 4, orother numbers, or reduced to one tissue attachment member. The locationsof the additional tissue stabilizers may also vary radially andlongitudinally along the lead body.

As discussed above and herein, and as shown in FIG. 12b , for example,the tissue stabilizers or attachment members (wire loops) 141/141 a and142/142 a may have a looped end with a constant radius when in thedeployed configuration. This radius may practically range from 1 mm to 5mm, but is not so limited.

As shown in FIG. 12c , for example, the radius of the deployed tissuestabilizers 141/141 a and 142/142 a may decrease along the length of thewire loop end, from the proximal section of the loop to the distalsection of the loop. Alternatively or in combination, the radius of thedeployed tissue stabilizers 141/141 a and 142/142 a may increase alongthe length of the wire loop end, from the proximal section of the loopto the distal section of the loop.

As shown in FIGS. 13a and 13b , the length of the deployment port 230 afor the attachment members or tissue stabilizers 141 a and 142 a may belengthened to allow the lead body 120 to translate over the linearportion of the tissue stabilizer wire 140 a (within the lead body 120).This allowance of movement of the lead body 120 over the stabilizerwire(s) 140 a can permit the lead 100 a to move freely in response tointra-cardiac forces during contraction, while the tissue stabilizerloops 141 a, 142 a remain securely implanted in the myocardium. FIGS.13a and 13b show the position of the stabilizers 141 a, 142 a whentranslated to the distal end of the deployment port 230 a (FIG. 13a )and the proximal end of the deployment port 230 b (FIG. 13b ).

As shown in FIG. 14, the attachment members or tissue stabilizers 141 a,142 a may have distal segments of the end wire loop that are somewhatstraightened, such that upon the initial deployment of the end wireloop, the straight distal segment may extend and “reach” furtherradially away from the lead body 120, before the “loop” segment of thewire emerges from the lead's deployment port 230 a. This can allow thetissue stabilizers 141 a, 142 a to purchase as much tissue as possibleto afford a secure attachment to the myocardium. As shown, thestraightened segment is at the distal tip of the attachment member ortissue stabilizer 141 a, 142 a; however, the straightened segment can belocated anywhere along attachment member or tissue stabilizer.

As shown in FIGS. 15a to 15c , tissue stabilizer members 141 b, 142 bmay be tubular in construction, e.g. a hypotube or hypodermic typeneedle. As shown in FIG. 15a , the tissue stabilizer members or needles141 b, 142 b may deploy from the common deployment port 230 a similar tothe manner described above and herein. It can be appreciated that thestabilizer needle(s) may also deploy from separate ports 240 of FIG. 7b. Within the tissue stabilizer members or needles 141 b, 142 b mayreside one or more translatable anchor-wires 141 c, 142 c, respectively,the distal end of the wires 141 c, 142 c being pre-shaped into a smallhelix, spiral, or pigtail, as an example, but not so limited. Thematerial chosen for the anchor-wires 141 c, 142 c may be of ashape-memory material to allow the pre-formed helix to straighten as thedistal ends of the anchor-wires 141 c, 142 c is translated within theneedles 141 b, 142 b, respectively, and then reform the helix, such aswhen penetrating tissue, as the distal ends of the anchor-wires 141 c,142 c are advanced beyond the ends of the needles 141 b, 142 c as shownin FIG. 15b . The needles 141 b, 142 b may penetrate into the targettissue, upon which the distal ends of the translatable anchor-wire 141c, 142 c may be advanced into the target tissue to reform the helix. Theneedles 141 b, 142 b may then be retracted back into the lead body 120as in FIG. 15c , leaving the anchor-wire and reformed helix implantedwithin the target tissue. The anchor-wires 141 c, 142 c may beconstructed from 0.002″-0.008″ diameter Nitinol wire, other shape-memoryalloy, or other shape-memory monofilament, braided or stranded material,though the wire or monofilament is not so limited to the diametersgiven.

As shown in FIG. 15c , the needle stabilizers 141 b, 142 b may beretracted back within the lead body 120. The anchor-wires 141 c, 142 cmay now also be slightly retracted back into the lead body to remove any“slack” in the straight section of the anchor wire 141 c, 142 c and topulling the lead body 120 and electrodes 131, 132 against the tissuesite where the distal end of the anchor-wires 141 c, 142 c areimplanted.

As shown in FIGS. 16a and 16b , the lead distal segment 100 a (placedinto the right ventricle RV) may have one or more large-diameter curvedbiasing-loops 141 d, 142 d for deploying and securing an attachment ofthe lead distal segment 120 to a cardiac structure (such as theinterventricular septum IVS separating the right ventricle RV with theleft ventricle LV). These biasing-loops 141 d, 142 d may be deployableand retractable similarly to the tissue stabilizers described above andherein. As the biasing-loops 141 d, 142 d are deployed, they may havesufficient “reach” to engage the tissue opposite the lead body 120 asshown in FIG. 16a . In some embodiments, no balloon inflation isnecessary to wedge the lead body 120 against the interventricular septum(that is, the deployment of the biasing-loops 141 d, 142 d may besufficient to push and position the lead body 120 as desired). Thus, asthe distal ends of the biasing-loops 141 d, 142 d engage the tissueopposite the lead body 120 (free wall tissue in FIGS. 16a, 16b ) thelead body 120 can be moved in the opposite direction and against theinterventricular septum IVS, i.e. the lead 120 and deployedbiasing-loops 141 d, 142 d may now be wedged between the ventricularfree wall and interventricular septum IVS, as an example. In someembodiments, the biasing-loops 141 d, 142 d may comprise electrodes suchthat the biasing-loops 141 d, 142 d may serve as pacing leads.

Further, each biasing-loop 141 d, 142 d may also have a sharpened distalend to penetrate tissue and/or include translatable anchor-wires 141 c,142 c, as described above and herein. FIG. 16b shows the translatableanchor-wires 141 c, 142 c being deployed from the distal end of thebiasing-loops 141 d, 142 d. The lead distal segment 120 of FIG. 16b isshown in FIG. 16c without the heart to provide a better image of thebiasing-loops 141 d, 142 d and the anchor-wires 141 c, 142 c.

In the FIG. 16c , the anchor-wires 141 c, 142 c are shown to emerge froma port located on the side of the biasing-loops 141 d, 142 d, however,the anchor-wires 141 c, 142 c may alternatively emerge from the distalends of the biasing loops 141 d, 142 d. The distal ends of the biasingloops 141 d, 142 d may penetrate the tissue, or the distal segments ofthe biasing-loops 141 d, 142 d may simply rest against the tissue. Ineither case, the distal lead segment 100 a may be biased away from thebiasing-loops 141 d, 142 d and against the target tissue (tissue to bepaced by the electrodes 131, 132). FIG. 16c shows a single anchor-wire141 c, 142 c extending from biasing-loops 141 d, 142 d, respectively,but in some embodiments, multiple anchor-wires may extend from a singlebiasing loop 141 d or 142 d.

With respect to the deployment of the stabilizers 141/141 a, 142/142 a,the stabilizer-needles 141 b, 142 b, or the biasing-loops 141 d, 142 d(“deployable members”), proper radial deployment of these members141/141 a, 142/142 a, 141 b, 142 b, 141 d, 142 d may require precisecontrol. If these member 141/141 a, 142/142 a, 141 b, 142 b, 141 d, 142d are allowed to simply rest within the deployment lumen 222 of the leadbody 120, upon torqueing of the device the lead body 120 and thedeployable members 141/141 a, 142/142 a, 141 b, 142 b, 141 d, 142 d mayexperience different amounts of torsion and thus the deployment members141/141 a, 142/142 a, 141 b, 142 b, 141 d, 142 d may lose theirdeployment alignment with the deployment port 230, 230 a of the leadbody 120. Thus, “keying” of the deployable members 141/141 a, 142/142 a,141 b, 142 b, 141 d, 142 d within the deployment lumen may be criticalto maintain the deployment member's deployment alignment to thedeployment port.

Techniques for such “keying” are shown, for example, in FIGS. 17a and17b . The straight segment of each stabilizer wire 141 a, 142 a may beflattened, and when mated they form a square cross-section that cantranslate in a stainless steel hypotube 1610, the inner diameter ofwhich can be precision shaped into a square cross-section (the “key”).Thus, as the stabilizers 141 a, 142 b are translated back and forth(deployment and retraction) the stabilizer wires 141 a, 142 b may remainaligned within the stainless steel hypotube 1610 shaped with a matingsquare cross-sectional profile. While the “key” may have a squarecross-section, other shapes such as a rectangle, triangle, trapezoid,pentagon, to name a few, may also be used.

Further, the “key” should not move or rotate within the deployment lumen222 a of the lead body 120. Thus the key must be secured (glued, bonded)within the deployment lumen of the lead body 120. Thus, to secure the“key,” another component, a “guide tube” 1600, may be provided. Thekey-guide tube assembly 140 a′ may be inserted into the deployment lumen222 of the lead body 120 and affixed in place using adhesives. The“guide tube” 1600 may serve many purposes: (1) it can securely hold the“key” in place within the deployment lumen 222 a, and (2) it can alsoserve as a secure containment “garage” as the tips of the stabilizers141 a, 142 a are fully retracted within the lead body 120. With respectto the latter function—if the stabilizers tips are retracted to withinthe deployment lumen 222 a of the lead body 120 (lead body 120 may be ofa lower durometer polymer), the tips can dig into the polymer, thushalting their deployment. However, the “guide tube” 1600 may befabricated from a material with a hard surface finish (e.g. Nitinol,high durometer Hytrel polymer, Nylon, to name a few) such that thestabilizer tips may glide along the inner surface of the guide tube1600, allowing free retraction and deployment of the stabilizers 141 a,142 a. As shown in FIG. 17b , the guide tube 1600 can be mounted withinthe deployment lumen 222 a of the lead body 120. In many embodiments, afluid tight seal 1630, such as an O-ring, may be provided between theinner surface of the guide-tube 1600 and the tissue attachment mechanismto prevent fluid leakage in the proximal direction through theguide-tube 1600.

In some embodiments, the “key” need not be mounted within the “guidetube” 1600 to form an assembly 140 a′ that is mounted within the lead'sdeployment lumen 222 a. The “key” may be mounted separate from the“guide tube” 1600 either proximal to the guide tube 1600 or distal tothe guide tube 1600. Note that if the “key” is mounted distal to theguide tube 1600 the stabilizers 141 a, 142 a may also be flattened alongthe loops—such that when the stabilizers 141 a, 142 a are retracted,their mated cross-sectional shape (a square) can be retracted into thesquare cross-sectional shape of the guide tube's inner diameter.

In other embodiments, the guide tube 1600 may be designed and extrudedfrom a high durometer polymer, such as Hytrel or nylon, with a squareinner lumen. Thus, a separate “key” may not be necessary.

Lead and External Generator Connection

Referring now to FIG. 24a-24c , in some embodiments, the electricalsensing/stimulation device or temporary pacing lead 10 may comprise leadconnector plugs 2403 coupled to the proximal portion of the distal leadbody 100 or 100 a to power the electrodes 131 and 132. The connectorplugs 2503 may connect or plug into an external generator 2501. Theconnector plugs 2503 may fit tightly into the external generator 2401.

In at least some cases, it may be desirable to have the connector plugs2403 easily disconnect from the external generator 2401, particularly ifpulled or tugged relative to the external generator 2401. For example,the connection between the connector plugs 2403 and the externalgenerator 2401 may be at least in part magnetic. The strength of themagnetic connection may be tuned, such as by selecting an appropriatelysized magnet, such that the connector plugs 2403 can disconnect from theexternal generator 2401 under a given force or displacement. To providethe magnetic connection, a magnetic connection hub 2405 may be providedas shown in FIGS. 24b and 24c . FIG. 24b shows the external generator2401, the connector plugs 2403, and the magnetic connection hub 2405 asdisconnected and FIG. 24c shows these elements as connected together.The proximal ends of the connector plugs 2403 may comprise magnets 2407with a first polarity complementary to magnets 2409 with a secondopposite polarity of the magnetic connection hub 2405. The magneticconnection hub 2405 may comprise conductors 2411 which may electricallycouple the electrode wires of the connector plugs 2403 with theelectrical outlets of the external generator 2401. The magneticconnection hub 2405 may form a tightly fitted connection with theexternal generator 2401.

In at least some cases, the distal lead segment 100 or 100 a may tend tomove away from the apex of the heart when the patient moves away fromthe external generator 2401 while an introducer sheath used to introducethe electrical sensing/stimulation device remains stationary relative tothe patient. It may be desired that this movement of the distal leadsegment 100 or 100 a be reduced or eliminated. In some embodiments, aretractable extension cord may be provided. A retractable extension cord2501 may be provided between the temporary pacing lead 10 as shown inFIGS. 25a to 25f . Alternatively, a retractable extension cord 2651 maybe integrated into the temporary pacing lead 10 itself as shown in FIG.26 g.

As shown in FIGS. 25a to 25f , the retractable extension cord adaptor2501 may be an interface between the temporary pacing lead 10 and theexternal generator 2401. The retractable extension cord adapter 2501 maycomprise a torsional device 2503, a proximal cord 2505, distal cords2507, and a connector 2509 which connects to the external generator2401. At least a portion of the cords 2505, 2507 may wind about thetorsional device 2503 as shown in FIGS. 25d, 25e, and 25f . Thetorsional device 2503 may provide a bias for the retractable extensioncord adapter 2501 to be in an axially retracted configuration as shownin FIGS. 25a and 25b . In the axially retracted configuration shown inFIG. 25b , the distance between the external generator 2401 and thetorsional device 2503 may be a first length 2505 a spanned by theproximal cord 2505 and the distance between the torsional device 2503and the ends of the distal cord 2507 may be a second length 2507 aspanned by the distal cords 2507. An axial force 2511 may be applied topull the retractable extension cord adapter 2501 into an axiallystretched or extended configuration. The magnitude (or strength) of theaxial force 2511 can be tuned, such as by selecting an appropriatelysize torsional spring with the desired torsional spring constant. In theaxially stretched or extended configuration shown in FIG. 25c , thedistance between the external generator 2401 and the torsional device2503 may be a third length 2505 b greater than the first length 2505 aand spanned by the proximal cord 2505, and the distance between thetorsional device 2503 and the ends of the distal cord 2507 may be afourth length 2507 b greater than second length 2507 a and spanned bythe distal cords 2507. FIG. 25f shows an exploded view of the torsionaldevice 2503, which may comprise a top fixture 2513, a bottom fixture2515, a torsional spring 2517, geared teeth 2623, a latch 2519, and atorsional spring 2521 between the latch 2519 and the bottom fixture2515. When the axial force 2511 is applied, the torsional device 2503may unravel and when the force is removed, the latch 2519 may preventthe cords 2505 and 2507 from retracting. The latch 2519 may be opened sothe cords 2505 and 2507 may be wound back into the torsional device2503. In combination with the torsional device 2503, a magneticconnection or coupling as described above may also be used.

Tissue Stabilizer Movement Detection

In at least some cases, it may be desirable to detect or measure themovement of the tissue attachment members 141 or 142 (or any of theattachment member(s) described above and herein) when engaging tissue.

An arrangement to detect or measure the movement of tissue attachmentmembers 141, 142 is shown in FIG. 26a . The attachment members 141, 142may be coupled to a magnet 2601 within the distal lead segment 100 or100 a. The magnet 2601 may translate within an inner lumen of the distallead segment 100 or 100 a when the attachment members 141, 142 aremoved. Such movement may be relative to and within a conductive tube2603 within the distal lead segment 100 or 100 a and may generate acurrent measurable through wire 2605 which is connected to theconductive tube 2603. The current may pass through a resistor attachedto ground so that a voltage measurement may be obtained. The measuredvoltage can be amplified and variations in voltage readings willtherefore correlated to displacement of the attachment members.

Another arrangement to detect or measure the movement of tissueattachment members 141, 142 is shown in FIG. 26b . The attachmentmembers 141, 142 may be coupled to a magnet 2601 within the distal leadsegment 100 or 100 a. The magnet 2701 may translate within the lumen ofthe distal lead segment 100 or 100 a when the attachment members 141,142 are moved. Such movement may be relative to and within a conductivetube 2603 within the distal lead segment 100 or 100 a. A first wire 2631may be connected to the magnet 2601, a second wire 2633 may be connectedto the conductive tube 2603, and the first and second wires 2631, 2633may be connected to a Wheatstone-bridge 2635. The movement of the anchor141, 142 may increase or decrease the distance 2630 and change theresistance from node 2635A to node 2635B in the Wheatstone-bridge 2635.The output of the Wheatstone-bridge 2635 may be input to an amplifier2637, and changes to the output voltage 2639 may be detected and may beindicative of movement of the anchor 141, 142.

Movement of the anchors 141, 142 may be detected and indicated to theuser, such as through the LCD (liquid crystal display) display 2652 of ahandle 2650 coupled to the distal lead segment 100 or 100 a as in FIG.26c or through LEDs or LED (light emitting diode) display 2654 of thehandle 2650 as in FIG. 26d . FIG. 26e shows a schematic of the circuitryof the handle 2650. The handle 2650 may comprise a microcontroller orMCU 2656 which may be coupled to one or more of the Wheatstone-bridge2635, the amplifier 2637, or a current sensing circuit 2658. The LEDdisplay 2652 and/or the LED display 2654 may be coupled to themicrocontroller 2656.

The handle 2650 may comprise other control and/or display mechanisms forthe distal lead segment 100 or 100 a. For example, the handle 2650 maycomprise one or more knobs, switches, buttons, sliders, or the like forone or more of deploying the tissue attachment members, activating theelectrodes, or expanding the expandable displacement member. The LCDdisplay 2652 or LED display 2654 may additionally indicate capacitivechanges, resistance changes, pressure changes, or the like that mayoccur as the distal lead segment 100, 100 a is used in interacting withtissue.

Lead Torque Control and Lead Shaping

Referring now to FIGS. 27a and 27b , many embodiments may includefeatures for torque control and/or shaping of the distal lead segment100 or 100 a. The lead body 120 may have an inner lumen through which aninternal shaping wire 2710 may be translated. The internal shaping wire2710 may allow a user to bend and shape the distal lead segment 100 or100 a and facilitate its passage through the vasculature. The internalshaping wire 2710 may be biased to have a curved end such that itimparts the same curved shape to the distal lead segment 100 or 100 a asshown in FIG. 27a . When the distal lead segment 100 or 100 a isadvanced through the vasculature, the curve placed on the distal leadsegment 100 or 100 a can naturally “align” the distal lead segment 100or 100 a to the vascular path. As an example, if the distal lead segment100 or 100 a is navigated to the right ventricle from the femoral vein,the pre-shaped curve (a large U-shape as shown in FIG. 27a ) may alignitself along the path from the inferior vena cava, into the rightatrium, through the tricuspid valve, and into the right ventricle. Thepre-shaped curve may straighten as needed to traverse straightersegments of the insertion path but may retain its curvilinear shape tonavigate turns in the path toward the target tissue.

In some embodiments, multiple shaping wires may be applied. For example,a first internal shaping wire may be used to help advance the distallead segment 100 or 100 a through a first portion of the vasculature anda second internal shaping wire with a different shape may be used tohelp advance the distal lead segment 100 or 100 a through a secondportion of the vasculature.

The internal shaping wire 2710 may be used alone or in conjunction witha torque control member 2720. The torque control member 2720 maycomprise a tube or hypotube translatable or bonded within the innerlumen of the lead body 120. The internal shaping wire 2710 may reside inthe torque control member 2720 as shown in FIG. 27b . Alternatively, theinternal shaping wire 2710 may reside in in the lead body 120 adjacentthe torque control member 2720. The torque control member 2720 mayreside within the lead body 120 and in some embodiments, may be bondedto the lead body 120 such that the two may act as a single component.Thus, as the proximal portion of the lead body 120 is turned or torqued,the distal lead segment 100 or 100 a can follow as shown by the arrows2701 a, 2701 b in FIG. 27 a.

In some embodiments, the internal shaping wire 2710 is unattached to thelead body 120 and/or torque member 2720 such that the torque member 2720and the lead body may rotate about the curved axis of the shaping wireas shown by the arrows 2701 a, 2701 b in FIG. 27 a.

While preferred embodiments have been shown and described herein, itwill be apparent to those skilled in the art that such embodiments areprovided by way of example only. Numerous variations, changes, andsubstitutions will now occur to those skilled in the art withoutdeparting from the scope of the present disclosure. It should beunderstood that various alternatives to the embodiments described hereinmay be employed in practicing the inventions of the present disclosure.By way of non-limiting examples, it will be appreciated by those skilledin the art that particular features or characteristics described inreference to one FIG. or embodiment may be combined as suitable withfeatures or characteristics described in another FIG. or embodiment. Itis intended that the following claims define the scope of the inventionand that methods and structures within the scope of these claims andtheir equivalents be covered thereby.

What is claimed is:
 1. An electrical sensing/stimulation apparatus forpositioning at least one electrode within body tissue, the electricalsensing/stimulation apparatus comprising: an elongate lead body having alongitudinal axis; at least one sensing/stimulation electrode coupled tothe elongate lead body; a deployable/retractable displacement membercoupled to the elongate lead body and adapted to move or bias the atleast one electrode towards a prescribed direction by a user; and atissue attachment mechanism adapted to affix a distal segment of theelongate lead body to body tissue, the tissue attachment mechanismhaving a retracted configuration and a deployed configuration, whereinin the retracted configuration the tissue attachment mechanism ispositioned substantially within the at least one internal lumen, and inthe deployed configuration the tissue attachment mechanism extends fromthe longitudinal axis of the elongate lead body to engage body tissue,and wherein the tissue attachment mechanism comprises a plurality oftissue attachment members adapted to extend from a common port of theelongate lead body, and wherein two or more of the tissue attachmentmembers of the plurality of tissue attachment members are adapted todiverge from one another when extended from the common port.
 2. Theelectrical sensing/stimulation apparatus of claim 1, wherein theelongate lead body has one or more ports through which the tissueattachment mechanism is configured to deploy.
 3. The electricalsensing/stimulation apparatus of claim 1, wherein a proximal portion ofthe elongate lead body is configured to couple with an externalgenerator.
 4. The electrical sensing/stimulation apparatus of claim 3,wherein the proximal portion of the elongate lead body is configured tocouple with the external generator through a magnetic coupling.
 5. Theelectrical sensing/stimulation apparatus of claim 3, wherein theproximal portion of the elongate lead body is configured to couple withthe external generator through an extension coupling adapted to axiallylengthen or contract.
 6. The electrical sensing/stimulation apparatus ofclaim 1, wherein the at least one sensing/stimulation electrodecomprises a first electrode and a second electrode.
 7. The electricalsensing/stimulation apparatus of claim 6, wherein thedeployable/retractable displacement member is disposed between the firstand second electrodes.
 8. The electrical sensing/stimulation apparatusof claim 1, wherein the deployable/retractable displacement membercomprises an expandable member having a collapsed configuration and anexpanded configuration.
 9. The electrical sensing/stimulation apparatusof claim 8, wherein the expandable member is adapted to deploy out of alateral side of the elongate lead body.
 10. The electricalsensing/stimulation apparatus of claim 8, wherein the expandable memberin the collapsed configuration does not extend from an outer surface ofthe elongate lead body.
 11. The electrical sensing/stimulation apparatusof claim 8, wherein the expandable member is at least partially foldedonto itself in the collapsed configuration.
 12. The electricalsensing/stimulation apparatus of claim 8, further comprising aradiopaque marker mounted on an outer surface of the expandable member.13. The electrical sensing/stimulation apparatus of claim 12, whereinthe radiopaque marker is expandable in conjunction with the expandablemarker.
 14. The electrical sensing/stimulation apparatus of claim 12,wherein the expandable element in the expanded configuration is shapedto match the cavity of a bodily organ or space.
 15. The electricalsensing/stimulation apparatus of claim 14, wherein the bodily organ orspace is at least a part of a right ventricle, a left ventricle, a rightatrium, a left atrium, an aorta, a vena cava, an artery, a vein, abladder, a ureter, a uterus, a nasal cavity, an oral cavity, anesophagus, a stomach, an intestine, a gall bladder, a colon, or arectum.
 16. The electrical sensing/stimulation apparatus of claim 1,wherein in the deployed configuration, the tissue attachment mechanismextends from the longitudinal axis of the elongate lead body topenetrate into the body tissue.
 17. The electrical sensing/stimulationapparatus of claim 1, wherein the plurality of tissue attachment membersis adapted to extend from the longitudinal axis of the elongate leadbody.
 18. The electrical sensing/stimulation apparatus of claim 1,wherein one or more tissue attachment member of the plurality of tissueattachment members comprises a curved loop.
 19. The electricalsensing/stimulation apparatus of claim 1, wherein two or more tissueattachment members of the plurality of tissue attachment members areconfigured to extend from different ports of the elongate lead body. 20.The electrical sensing/stimulation apparatus of claim 19, wherein thetwo or more of the tissue attachment members of the plurality of tissueattachment members are adapted to be co-planar when extended.
 21. Theelectrical sensing/stimulation apparatus of claim 1, wherein the commonport has a length allowing the elongate lead body to translate over alinear portion of one or more of the tissue attachment members.
 22. Theelectrical sensing/stimulation apparatus of claim 21, wherein one ormore of the tissue attachment members have a distal wire loop and astraightened distal-most portion distal of the distal wire loop.
 23. Theelectrical sensing/stimulation apparatus of claim 1, wherein two or moreof the tissue attachment members diverge from one another by an angle ofless than or equal to 270 degrees.
 24. The electricalsensing/stimulation apparatus of claim 1, wherein the at least onetissue attachment member comprises a hollow needle having an inner lumenthrough which one or more anchoring elements are advanced from when theat least one tissue attachment member is deployed.
 25. The electricalsensing/stimulation apparatus of claim 1, further comprising anatraumatic distal lead body termination.
 26. The electricalsensing/stimulation apparatus of claim 25, wherein the atraumatic distallead body termination comprises a sensing/stimulation electrode.
 27. Theelectrical sensing/stimulation apparatus of claim 1, further comprisinga proximal handle coupled to the elongate lead body.
 28. The electricalsensing/stimulation apparatus of claim 1, wherein the proximal handlecomprises one or more controls for one or more of activating the atleast one sensing/stimulation electrode, deploying or retracting thedeployable/retractable displacement member, or deploying or retractingthe tissue attachment mechanism.
 29. The electrical sensing/stimulationapparatus of claim 1, wherein the proximal handle comprises one or moredisplays for indicating one or more of a relative position of the tissueattachment mechanism, a sensed resistance of tissue engaged by thetissue attachment mechanism, or a sensed amount of current through thetissue engaged by the tissue attachment mechanism.
 30. The electricalsensing/stimulation apparatus of claim 1, wherein the elongate lead bodyhas an internal lumen, and wherein the electrical sensing/stimulationapparatus further comprises a torque member within the inner lumen andadapted to torque the elongate lead body.
 31. The electricalsensing/stimulation apparatus of claim 30, wherein the torque member isfixedly attached to the elongate lead body.
 32. The electricalsensing/stimulation apparatus of claim 30, wherein the torque membercomprises a hypotube.
 33. The electrical sensing/stimulation apparatusof claim 30, further comprising a shaping wire configured for placementwithin the internal lumen of the elongate lead body to provide apredetermined shape to the elongate lead body.
 34. The electricalsensing/stimulation apparatus of claim 33, wherein the shaping wire isconfigured to axially translate within the inner lumen.
 35. Theelectrical sensing/stimulation apparatus of claim 1, wherein theelongate lead body comprises an O-ring disposed in a proximal portionthereof, the O-ring being adapted to prevent fluid from leakingproximally therethrough.
 36. A method for positioning an electricalsensing/stimulation device within body tissue, the method comprising:advancing an elongate lead body of the electrical sensing/stimulationdevice to position the elongate lead body at a target site in a bodilycavity; torqueing the elongate lead body to align at least one tissueattachment member of the electrical sensing/stimulation device with atarget tissue in the target site; deploying a displacement member tobias the elongate lead body and the at least one tissue attachmentmember against the target tissue; and actuating the at least one tissueattachment member to extend from at least one tissue anchor deploymentport on the elongate lead body and into the target tissue to affix adistal portion of the elongate lead body and at least one electrode ofthe electrical sensing/stimulation device to the target tissue, whereinthe at least one tissue attachment member comprises a plurality oftissue attachment members, and wherein actuating the at least one tissueattachment member to extend from the at least one tissue deployment portcomprises actuating the plurality of tissue attachment members to extendfrom a common tissue deployment port, and wherein two or more attachmentmembers diverge from one another when deployed from the common tissuedeployment port.
 37. The method of claim 36, further comprisingverifying proper affixation of the distal portion of the elongate leadbody to the target tissue.
 38. The method of claim 37, wherein verifyingproper affixation of the distal portion of the elongate lead body to thetarget tissue comprises fluoroscopically imaging the bodily cavity withthe elongate lead body positioned therein.
 39. The method of claim 38,wherein fluoroscopically imaging the bodily cavity comprises identifyingone or more radiopaque markers coupled to one or more of the elongatelead body, the at least one tissue attachment member, or thedisplacement member.
 40. The method of claim 36, further comprisingsensing a physiological parameter with the at least one electrodeaffixed to the target tissue.
 41. The method of claim 36, furthercomprising stimulating the target tissue with the at least oneelectrode.
 42. The method of claim 36, further comprising collapsing thedisplacement member and retracting the at least one tissue attachmentmember after affixation to the target tissue, so as to release theaffixation of the distal portion of the elongate lead body and the atleast one electrode from the target tissue.